T:FLEX INSULIN DELIVERY SYSTEM

INFUSION PUMP

This device is manufactured by TANDEM DIABETES CARE.

The following problems were reported about this device:

Year Description Events/year Type
2024 Failure to Sense 1 Device
2024 Device Sensing Problem 1 Device
2024 Crack 1 Device
2023 Pumping Stopped 3 Device
2023 Obstruction of Flow 2 Device
2023 Incorrect Measurement 2 Device
2023 Failure to Sense 1 Device
2023 Device Sensing Problem 1 Device
2023 Date/Time-Related Software Problem 1 Device
2023 Battery Problem 1 Device
2022 Pumping Stopped 10 Device
2022 Physical Resistance/Sticking 1 Device
2022 Obstruction of Flow 2 Device
2022 Mechanical Problem 2 Device
2022 Material Twisted/Bent 1 Device
2022 Loose or Intermittent Connection 1 Device
2022 Insufficient Information 3 Device
2022 Incorrect Measurement 8 Device
2022 Filling Problem 1 Device
2022 Failure to Sense 1 Device
2022 Device Sensing Problem 1 Device
2022 Charging Problem 5 Device
2022 Battery Problem 3 Device
2022 Adverse Event Without Identified Device or Use Problem 1 Device