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Important Safety Information: MiniMed Flex^TM system with SmartGuard^TM technology with Simplera Sync^TM sensor

The MiniMed Flex^TM system is intended for the continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable rates for the management of type 1 diabetes mellitus in persons 7 years of age and older, and of type 2 diabetes mellitus in persons 18 years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed Flex^TM system includes SmartGuard^TM technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.

The Simplera Sync^TM sensor can be used one time and has a life up to 6 days, followed by a grace period of 24 hours. During the grace period, the sensor will continue to work as it did during the first 6 days, to allow the patient to change their sensor more flexibly. However, some sensors may not survive the full wear period for a variety of reasons. Please be prepared to replace the sensor during the grace period to ensure sensor glucose values continue to be monitored.

The Simplera Sync^TM sensor is not intended to be used directly to make therapy adjustments while the MiniMed Flex^TM system 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 Simplera Sync^TM sensor. The Simplera Sync^TM 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 Simplera Sync^TM sensor in the abdomen or other body sites, including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia.

The Medtronic MiniMed Flex^TM System consists of the following devices: MiniMed Flex^TM Insulin Pump and the Simplera Sync^TM sensor. The system requires a prescription from a healthcare professional.

WARNING: Do not use the SmartGuard^TM 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^TM feature.  

WARNING: Do not use the MiniMed Flex^TM system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed Flex^TM 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^TM 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 blood glucose (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 Flex^TM system has not been studied in pregnant women or in persons using other anti-hyperglycemic therapies that do not include insulin. For complete details of the system, including user guides and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, see https://bit.ly/MiniMedRisks.