MiniMed™ 630G system discontinuation

Important Safety Information: MiniMed^™ 780G System With SmartGuard^™ Technology With Guardian^™ 4 Sensor

The MiniMed^™ 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed^™ 780G system includes SmartGuard^™ technology, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values.

The Medtronic MiniMed^™ 780G system consists of the following devices: MiniMed^™ 780G insulin pump, the Guardian^™ 4 transmitter, the Guardian^™ 4 sensor, One-press serter, the Accu-Chek^™ Guide Link blood glucose meter, and the Accu-Chek^™ Guide test strips. The system requires a prescription from a healthcare professional.

The Guardian^™ 4 sensor is intended for use with the MiniMed^™ 780G system and the Guardian 4 transmitter to monitor glucose levels for the management of diabetes. The sensor is intended for single use and requires a prescription. The Guardian^™ 4 sensor is indicated for up to seven days of continuous use.

The Guardian^™ 4 sensor is not intended to be used directly to make therapy adjustments while the MiniMed^™ 780G is operating in manual mode. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian^™ 4 sensor. The Guardian^™ 4 sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the Guardian^™ 4 sensor in the abdomen or other body sites including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia.

WARNING: Do not use the SmartGuard^™ feature for people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to operate in the SmartGuard^™ feature.

WARNING: Do not use the MiniMed^™ 780G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed^™ 780G system.

WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump is in Manual Mode. When the SmartGuard^™ feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if your symptoms do not match the SG value, use a BG meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the infusion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.

Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms. The safety of the MiniMed^™ 780G system has not been studied in pregnant women, persons with type 2 diabetes, or in persons using other anti-hyperglycemic therapies that do not include insulin. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult https://www.medtronicdiabetes.com/important-safety-information#minimed-780g and the appropriate user guide at https://www.medtronicdiabetes.com/download-library

Important Safety Information: MiniMed™ 630G system with SmartGuard™ technology

Indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus. MiniMed™ 630G system is approved for ages 14 years or older with Guardian™ Sensor 3 and MiniMed™ 630G system is approved for ages 16 years or older with Enlite™ sensor. Both systems require a prescription. Insulin infusion pumps and associated components of insulin infusion systems are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks of insulin pump therapy. Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms.

Insulin pumps use rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately. Replace the infusion set every 48–72 hours, or more frequently per your healthcare professional’s instructions.

Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected.

The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a blood glucose meter. A confirmatory fingerstick using a CONTOUR®NEXT LINK 2.4 meter is required prior to making adjustments to diabetes therapy. Always check the pump display when using a CONTOUR®NEXT LINK 2.4 meter, to ensure the glucose result shown agrees with the glucose results shown on the meter. Do not calibrate your CGM device or calculate a bolus using a result taken from an Alternative Site (palm) or a result from a control solution test. If a control solution test is out of range, please note that the result may be transmitted to your pump when in the “Always” send mode. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise.

The MiniMed™ 630G system is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Suspend on low alarm and take measures to prevent or treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare provider.

WARNING: The SmartGuard™ Suspend on low feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again, resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the SmartGuard™ feature, it is important to read the SmartGuard™ feature information in the User Guide and discuss proper use of the feature with your healthcare provider.

See https://www.medtronicdiabetes.com/important-safety-information and the appropriate user guides for additional important details