The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.
The pump is intended for single patient, home use and requires a prescription.
The pump is indicated for use in individuals six years of age and greater.
Control-IQ technology is intended for use with compatible interoperable continuous glucose monitors (iCGM), alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ technology is not a substitute for your own active diabetes management.
Control-IQ technology is approved for the management of Type 1 diabetes mellitus in persons six years of age and greater.
Control-IQ technology is intended for single patient use and requires a prescription.
DO NOT start to use your pump before reading the user guide. Failure to follow the instructions in this user guide can result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events. If you have questions or need further clarification on your pump use, ask your healthcare provider or call Customer Technical Support.
DO NOT start to use your pump before you have been appropriately trained on its use by a certified trainer or through the training materials available online. Consult with your healthcare provider for your individual training needs for the pump. Failure to complete the necessary training on your pump could result in serious injury or death.
ONLY use U-100 Humalog or U-100 NovoLog with your pump. Only U-100 Humalog and NovoLog have been tested and found to be compatible for use in the pump. Use of insulin with greater or lesser concentration can result in an over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.
DO NOT put any other drugs or medications inside your pump cartridge. The pump is designed only for continuous subcutaneous insulin infusion (CSII) using U-100 Humalog or U-100 NovoLog insulin. Use of other drugs or medications can damage the pump and result in injury if infused.
DO NOT use manual injections or inhaled insulins while using the Tandem Mobi pump. Using insulin not provided by the pump can cause the system to over deliver insulin, which can lead to severe hypoglycemia (low BG) events.
The pump is not intended for anyone unable or unwilling to:
The user must also have adequate vision and/or hearing in order to recognize all functions of the pump, including alerts, alarms, and reminders.
DO NOT start to use your pump before consulting with your healthcare provider to determine which features are most appropriate for you. Only your healthcare provider can determine and help you adjust your basal rate(s), carb ratio(s), correction factor(s), target BG, and duration of insulin action. In addition, only your healthcare provider can determine your CGM settings and how you should use your sensor trend information to help you manage your diabetes. Incorrect settings can result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.
ALWAYS be prepared to inject insulin with an alternative method if delivery is interrupted for any reason. Your pump is designed to deliver insulin reliably, but because it uses only rapid-acting insulin, you will not have long-acting insulin in your body. Failure to have an alternative method of insulin delivery can lead to very high BG or Diabetic Ketoacidosis (DKA).
ONLY use cartridges and infusion sets with matching connectors and follow their instructions for use. Failure to do so may result in over delivery or under delivery of insulin and may cause hypoglycemia (low BG) or hyperglycemia (high BG) events.
DO NOT place your infusion set on any scars, lumps, moles, stretch marks or tattoos. Placing your infusion set in these areas can cause swelling, irritation or infection. This can affect insulin absorption and cause high or low BG.
ALWAYS carefully follow the instructions for use accompanying your infusion set for proper insertion and infusion site care, as failure to do so could result in over delivery or under delivery of insulin or infection.
NEVER fill your tubing while your infusion set is connected to your body. Always ensure that the infusion set is disconnected from your body before filling the tubing. Failure to disconnect your infusion set from your body before filling the tubing can result in over delivery of insulin. This can cause hypoglycemia (low BG) events.
DO NOT change your infusion set before bedtime or if you will not be able to test your BG 1 to 2 hours after the new infusion set is placed. It is important to confirm that the infusion set is inserted correctly and delivering insulin. It is also important to respond quickly to any problems with the insertion to ensure continued insulin delivery.
ALWAYS insert infusion set and connect to the pump before applying the sleeve to ensure the tubing is not stretched. Failure to follow these steps could result in crimping or dislodgement at the infusion site, which could affect the performance of the cannula. This could lead to hyperglycemia (high blood glucose).
NEVER reuse cartridges or use cartridges other than those manufactured by Tandem Diabetes Care. Use of cartridges not manufactured by Tandem Diabetes Care or reuse of cartridges may result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.
ALWAYS follow the load sequence on your t:connect mobile app prior to loading a new cartridge on the pump.
ALWAYS ensure there is a tight connection between the cartridge tubing and the infusion set tubing. A loose connection can cause insulin to leak, resulting in under delivery of insulin. This can cause hyperglycemia (high BG) events.
DO NOT disconnect the tubing connector between the cartridge tubing and the infusion set tubing while delivering insulin. If the connection comes loose, disconnect the infusion set from your body before tightening. Failure to disconnect before tightening can result in over delivery of insulin. This can cause hypoglycemia (low BG).
DO NOT remove or add insulin from a filled cartridge after loading it onto the pump. This may result in an inaccurate display of the insulin level on the Dashboard screen, and an over or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.
DO NOT allow small children (either pump users or non-users) to ingest small parts, such as the cartridge components. Small parts could pose a choking hazard. If ingested or swallowed, these small component pieces may cause internal injury or infection.
The pump includes parts (such as the USB cable and infusion set tubing) that could pose a strangulation or asphyxiation hazard. ALWAYS use the appropriate length of infusion set tubing and arrange cables and tubing to minimize the risk of strangulation. ENSURE that these parts are stored in a secure place when not in use.
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30.5 cm) to any part of the Tandem Mobi insulin pump, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
ONLY use accessories, cables, adapters, and chargers provided by the manufacturer. Use of third-party equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
ALWAYS inspect your cartridge for signs of damage. ALWAYS replace the cartridge if it is damaged and ALWAYS suspend insulin and disconnect your infusion site before replacing the cartridge.
ALWAYS inspect your cartridge to ensure the cartridge is securely attached to the pump. ALWAYS suspend insulin and disconnect your infusion site if the cartridge rotates or is not securely attached to the pump before adjusting the cartridge.
AVOID excessive exposure of your cartridge when filled with insulin to direct sunlight as this may impact the effectiveness of insulin.
DO NOT expose your pump to a magnet, such as pump cases that have a magnetic clasp or common products which include magnets such as cellphones and wireless charging cases. Exposure to magnets or products with magnets may interfere with the pump motor. Damage to the motor can impact the pump’s functionality.
Some skin care products such as lotions, sunscreens, and insect repellents can cause cracks in the plastic used to manufacture the pump and cartridge. DO NOT allow these products to come in contact with the pump or cartridge. ALWAYS remove your pump before applying these products and ALWAYS wash your hands before handling your pump or cartridge after using such products. ALWAYS change your cartridge if it becomes exposed to such products and immediately clean your pump. Failure to do so may result in damage to the pump and cartridge and in some cases over or under delivery of insulin.
Magnetic Resonance Imaging Safety
The pump is magnetic resonance (MR) unsafe. You must take off your pump, transmitter, and sensor and leave them outside the procedure room.
Please review your smartphone manufacturer’s instructions before using the t:connect mobile app during any of the radiology or medical procedures listed below.
ALWAYS notify the provider/technician about your diabetes and your pump. If you need to discontinue use of the pump for medical procedures, follow your healthcare provider’s instructions to replace missed insulin when you reconnect to the pump. Check your BG before disconnecting from the pump and again when you reconnect and treat high BG levels as recommended by your healthcare provider.
DO NOT expose your pump, transmitter, or sensor to:
There is no need to disconnect for electrocardiograms (EKGs) or colonoscopies. If you have questions, contact Customer Technical Support.
DO NOT use the pump if you have a condition which, in the opinion of your healthcare provider, would put you at risk. Examples of individuals who should not use the pump include those with uncontrolled thyroid disease, renal failure (e.g. dialysis or eGFR <30), hemophilia, or another major bleeding disorder, or unstable cardiovascular disease.
DO NOT expose your pump, transmitter, or sensor to:
You must take off your pump, transmitter, and sensor and leave them outside the procedure room if you are going to have any of the above medical procedures.
There are other procedures where you should proceed with caution:
DO NOT start to use the t:connect mobile app before reading the user guide. Failure to follow the instructions in this user guide can result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events. If you have questions or need further clarification on the t:connect mobile app use, ask your healthcare provider or call Customer Technical Support.
DO NOT start to use the t:connect mobile app before you have been appropriately trained on its use by a certified trainer or through the training materials available online. Consult with your healthcare provider for your individual training needs for the t:connect mobile app. Failure to complete the necessary training on your t:connect mobile app could result in serious injury or death.
DO NOT start to use the t:connect mobile app before consulting with your healthcare provider to determine which features are most appropriate for you. Only your healthcare provider can determine and help you adjust your basal rate(s), carb ratio(s), correction factor(s), target BG, and duration of insulin action. In addition, only your healthcare provider can determine your CGM settings and how you should use your sensor trend information to help you manage your diabetes. Incorrect settings can result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.
ALWAYS confirm that your smartphone operating system (OS) update is compatible with the t:connect mobile app before updating your OS. If you update to an incompatible OS, you will lose the ability to adjust insulin and program your pump with the t:connect mobile app. Your pump will continue to operate as programmed. You will need to pair your pump with a compatible smartphone to be able to control the pump from your smartphone.
DO NOT use a smartphone that has been jailbroken or rooted. Data may become vulnerable if you install the t:connect mobile app on a smartphone that has been jailbroken or rooted, or uses an unreleased or pre-released operating system. Only download the t:connect mobile app from the App Store.
ALWAYS turn on notifications to receive your pump alerts, alarms, and notifications on your smartphone. Notifications must be enabled on your smartphone, and the t:connect mobile app must be open in the background for pump notifications to be received on your smartphone. If you close or force stop your t:connect mobile app, you will not receive these alerts, alarms, or notifications on your smartphone. All alerts and alarms will continue to annunciate on the pump.
Any time you request a bolus, you have 10 seconds to cancel the bolus after requesting it to completely avoid insulin delivery. The t:connect mobile app will display “BOLUS IN PROGRESS Requesting Bolus” during this time, and the pump LED status indicators will pulsate blue. You can cancel a bolus from the app regardless of how you requested it as long as your pump and the t:connect mobile app are connected.
DO NOT deliver a bolus until you have reviewed the calculated bolus amount on the t:connect mobile app display. If you deliver an insulin amount that is too high or too low, this could cause hypoglycemia (low BG) or hyperglycemia (high BG) events. You can always adjust the insulin units up or down before you decide to deliver your bolus.
The t:connect mobile app requires the use of the security feature that unlocks your smartphone to adjust insulin delivery and program the pump. ONLY users capable of independently making treatment decisions should have the ability to unlock the smartphone on which the t:connect mobile app is installed.
For patients whose insulin administration is managed by a caregiver, it is recommended to turn off the Quick Bolus feature to avoid inadvertent bolus delivery. Inadvertent Pump button presses could result in over delivery. This can cause hypoglycemia (low BG) events. However, if your smartphone is lost or damaged, you will NOT be able to deliver a bolus using your pump. Contact your healthcare provider for an alternate insulin delivery plan if your smartphone is not available and the Quick Bolus feature is not enabled.
DO NOT open or attempt to repair your insulin pump. The pump is a sealed device that should be opened and repaired only by Tandem Diabetes Care. Modification could result in a safety hazard. If your pump seal is broken, the pump is no longer water resistant and the warranty is voided.
CHANGE your infusion set every 48 to 72 hours as recommended by your healthcare provider. Wash your hands with anti-bacterial soap before handling the infusion set and thoroughly clean the insertion site on your body to avoid infection. Contact your healthcare provider if you have symptoms of infection at your insulin infusion site.
ALWAYS remove all air bubbles from the pump before beginning insulin delivery. Ensure there are no air bubbles when drawing insulin into the cartridge, hold the pump upright when filling the tubing, and ensure that there are no air bubbles in the tubing when filling. Air in the cartridge and tubing takes space where insulin should be and can affect insulin delivery.
CHECK your infusion site daily for proper placement and leaks. REPLACE your infusion set if you notice leaks around the site. Improperly placed sites or leaks around the infusion site can result in under delivery of insulin.
CHECK your infusion set tubing daily for any leaks, air bubbles, or kinks. Air in the tubing, leaks in the tubing, or kinked tubing may restrict or stop insulin delivery and result in under delivery of insulin.
CHECK the tubing connection between your cartridge tubing and infusion set tubing daily to ensure it is tight and secure. Leaks around the tubing connection can result in under delivery of insulin.
ALWAYS check that your cartridge has enough insulin to last through the night before going to bed. If you are sleeping, you could fail to hear the Empty Cartridge Alarm and miss part of your basal insulin delivery.
CHECK your pump’s personal settings regularly to ensure they are correct. Incorrect settings can result in over delivery or under delivery of insulin. Consult with your healthcare provider as needed.
ALWAYS make sure that the correct time and date are set on your insulin pump. Not having the correct time and date setting may affect safe insulin delivery. When editing time, always check that the AM/PM setting is accurate, if applicable. AM is to be used from midnight until 11:59 AM. PM is to be used from noon until 11:59 PM.
CONFIRM that you can feel the pump vibrate, and see the LED status indicators blinking above the Pump button when charging the pump. These features are used to notify you about alerts, alarms, and other conditions that require your attention. If these features are not working, discontinue use of the pump and contact Customer Technical Support.
CHECK your pump regularly for potential alarm conditions that may display. It is important to be aware of conditions that may affect insulin delivery and require your attention so you can respond as soon as possible.
DO NOT use the vibrate feature for alerts and alarms during sleep unless otherwise directed by your healthcare provider. Having the volume for alerts and alarms set to beep will help ensure that you don’t miss an alert or alarm.
ALWAYS look at the t:connect mobile app screen following confirmation of a Quick Bolus on the pump. Looking at the t:connect mobile app while you are getting familiar with the Quick Bolus feature will ensure that you are correctly using the beep/vibration commands to program the intended bolus amount.
ALWAYS monitor your BG for up to four hours after dropping or hitting the pump against a hard surface. Check that the pump is working properly by pressing the Pump button and ensuring the LEDs turn on, or placing it on a charging pad connected to a power source and confirming that you feel the pump vibrate, see the LED status indicators blinking above the Pump button, and by checking the t:connect mobile app. If your pump is damaged or you are unsure about potential damage, discontinue use of the pump and contact Customer Technical Support.
AVOID exposure of your pump to temperatures below 41°F (5°C) or above 99°F (37°C). Insulin can freeze at low temperatures or degrade at high temperatures. Insulin that has been exposed to conditions outside of the manufacturer’s recommended ranges can affect the safety and performance of the pump.
When fitted with a cartridge, newly manufactured pumps are water resistant (IP28) to a depth of 8 feet (2.4 meters) for up to 2 hours. Over time, the moisture protection capabilities of the pump may be compromised by incidental bumps, drops or other unintentional events the pump may be exposed to over time under normal use conditions. ALWAYS inspect your pump for damage. If there are signs of fluid entry, discontinue use of the pump and contact Customer Technical Support.
ALWAYS inspect your pump for damage or signs of fluid entry. If fluid leaks into your pump, it may cause the internal battery to overheat which may result in harm. If there are signs of fluid entry, discontinue use of the pump and contact Customer Technical Support.
AVOID areas where there may be flammable anesthetics or explosive gases. The pump is not suitable for use in these areas and there is a risk of explosion. Remove your pump if you need to enter these areas.
DO NOT wear or place your pump more than 12 inches (30.5 cm) above your infusion site. Doing so may result in over delivery of insulin.
DISCONNECT your infusion set from your body while on high-speed/high gravity amusement park thrill rides. Rapid changes in altitude or gravity can affect insulin delivery and cause injury.
DISCONNECT your infusion set from your body before flying in an aircraft without cabin pressurization or in planes used for aerobatics or combat simulation (pressurized or not). Rapid changes in altitude or gravity can affect insulin delivery and cause injury.
CONSULT your healthcare provider about lifestyle changes such as weight gain or loss, and starting or stopping exercise. Your insulin needs may change in response to lifestyle changes. Your basal rate(s) and other settings may need adjustment.
MONITOR your glucose levels during any significant changes in environmental temperature, pressure, and altitude as insulin delivery may be impacted. Examples may include snow skiing, driving on a mountain road, or ascending and descending in an airplane. Changes in delivery accuracy can affect insulin delivery and cause injury.
ALWAYS check with your healthcare provider for specific guidelines if you want or need to disconnect from the pump for any reason. Depending on the length of time and reason you are disconnecting, you may need to replace missed basal and/or bolus insulin. Check your BG before disconnecting from the pump and again when you reconnect, and treat high BG levels as recommended by your healthcare provider.
ENSURE that your personal insulin delivery settings are programmed into the pump before use if you receive a warranty replacement pump. Failure to enter your insulin delivery settings could result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events. Consult your healthcare provider as needed.
Interference with your pump’s electronics by smartphones can occur if worn in close proximity. It is recommended that your pump and smartphone be worn at least 6.4 inches (16.3 cm) apart.
ALWAYS dispose of used components such as cartridges, syringes, needles, infusion sets, and CGM sensors following the instructions from your healthcare provider and local regulations. Wash your hands thoroughly after handling used components.
When exposed to electrostatic discharge, the operation of the pump may be affected. Temporary disruption in wireless communications accompanied by notification may be observed. The pump may indicate a malfunction if wireless communication functionality is unable to recover.
DISCONTINUE use of the t:connect mobile app if your smartphone is damaged, or if a significant portion of its display is damaged or does not illuminate.
ALWAYS ensure your smartphone has established a Bluetooth wireless connection with your pump before you use the t:connect mobile app to make treatment decisions. Confirm that the information displayed to you matches your signs and symptoms.
The t:connect mobile app receives data from the connected pump via a secure Bluetooth wireless technology connection. If the Bluetooth connection between the pump and the t:connect mobile app is lost, the t:connect mobile app will not display current insulin pump information and cannot be used to adjust insulin delivery or to program your pump. To help maintain the wireless connection between the insulin pump and the t:connect mobile app, it is recommended the smartphone running the t:connect mobile app is within five feet of the compatible insulin pump.
ALWAYS turn Zoom Mode off when using the t:connect mobile app. If your smartphone has Zoom Mode turned on, you should not use the information displayed in the t:connect mobile app to make therapy decisions.
Use of mobile devices not complying with either IEC 60601-1, IEC 62368-1, or an equivalent standard may increase the risk of electrical hazards.
The pump provides an automated way to deliver basal and bolus insulin. Delivery can be fine-tuned based on up to six customizable Personal Profiles, each with up to 16 time-based settings for basal rate, carb ratio, correction factor, and target BG. In addition, the temp rate feature allows you to program a temporary basal rate change for up to 72 hours.
The pump gives you the option of delivering a bolus all at once, or delivering a percentage over an extended period of time without navigating to different menus. You can also program a bolus more discreetly using the Quick Bolus feature, which can be used without looking at the pump or t:connect mobile app, and can be programmed in increments of either units of insulin or grams of carbohydrate.
The pump keeps track of the amount of active insulin from food and correction boluses (IOB). When programming additional food or correction boluses, the amount of IOB will be subtracted from the recommended bolus if your BG is below the target set in your active Personal Profile. This can help prevent insulin stacking, which can lead to hypoglycemia (low BG).
You can program a number of reminders that will prompt you to retest your BG after a low or high BG is entered, as well as a “Missed Meal Bolus Reminder” which will alert you if a bolus isn’t entered during a specified period of time. If activated, these can help reduce the likelihood that you will forget to check your BG or bolus for meals.
You have the ability to view a variety of data on your t:connect mobile app screen, including the time and amount of your last bolus, your total insulin delivery by day, as well as broken into basal, food bolus, and correction bolus.
As with any medical device, there are risks associated with using your pump. Many of the risks are common to insulin therapy in general, but there are additional risks associated with continuous insulin infusion and continuous glucose monitoring. Reading your user guide and following the instructions for use are critical for the safe operation of your pump. Consult your healthcare provider about how these risks may impact you.
Inserting and wearing an infusion set might cause infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring, or skin discoloration).
There is a small chance that an infusion set cannula fragment could remain under your skin if the cannula breaks while you are wearing it. If you think a cannula has broken under your skin, contact your healthcare provider and call Customer Technical Support.
Other risks associated with infusion sets include occlusions and air bubbles in the tubing or dislodged cannula, which can affect insulin delivery. If your BG does not decrease after initiating a bolus, or you have other unexplained high BG, it is recommended that you check your infusion set for an occlusion or air bubbles, and verify that the cannula has not dislodged. If the condition persists, call Customer Technical Support or seek medical attention as required.
Risks that could result from pump failure include the following:
Any clinical language presented in this user guide is based on the assumption that you have been educated by your healthcare provider on certain terms and how they apply to you in your diabetes management. Your healthcare provider can help you establish diabetes management guidelines that best fit your lifestyle and needs.
Consult your healthcare provider before using the pump to determine which features are most appropriate for you. Only your healthcare provider can determine and help you adjust your basal rate(s), insulin-to-carbohydrate ratio(s), correction factor(s), target BG, and duration of insulin action. In addition, only your healthcare provider can determine your CGM settings and how you should use your sensor trend information to help you manage your diabetes.
You should always have an appropriate emergency kit with you. At the very least, this kit should include an insulin syringe and vial of insulin or a prefilled insulin pen with you as a backup for emergency situations. Talk with your healthcare provider regarding what items this kit should include.
Some examples of what to include in your everyday emergency kit are:
A power supply (AC adapter with charging pad) is provided with your pump. Before using your pump, ensure that the following occur when you place the pump on a powered charging pad:
CONFIRM that you can hear audible beeps, feel the pump vibrate, and see the LED status indicators illuminate when you place the pump on the center of the charging pad. These features are used to notify you about alerts, alarms, and other conditions that require your attention. If these features are not working, discontinue use of your pump and contact Customer Technical Support.
ALWAYS consult your healthcare provider if you suspect that your insulin delivery setting may have changed unexpectedly. ALWAYS pay attention to pump notifications, alerts, and alarms as they may indicate that someone else is trying to interference with your pump. If you ever suspect that someone else is trying to connect or interfere with your pump, stop using it and contact Customer Technical Support immediately.
The system is designed to work safely and effectively in the presence of wireless devices typically found at home, work, retail stores, and places of leisure where daily activities occur.
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30.5 cm) to any part of the Tandem Mobi pump, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
The system is designed to send and accept Bluetooth wireless technology communication. Communication is not established until you enter the appropriate credentials into your system. The system is designed to ensure data security and patient confidentiality using a series of cybersecurity measures, including device authentication, message encryption, and message validation.
The pump only accepts communications from a known linked device such as a CGM or personal smartphone. You must pair each device with your pump. The pump wireless communications are protected with encryption and authentication.
Always install pump software updates as they are made available by Tandem. Software updates may contain security enhancements necessary to maintain device cybersecurity. Tandem will notify you by communication channels such as emails and website pages when pump software updates are available.