It turned out that the application had serious software problems that could cause life-threatening conditions or even death. Although fortunately no deaths were reported, FDA receives 224 injury reports As of April 15.

Detail

According to the agency, there was a bug in version 2.7 of the t:connect mobile app that triggered an action loop that caused the app to crash and then repeatedly launch the app on the iOS platform. This can lead to overuse of Bluetooth communication, causing the pump battery to become severely drained and causing it to close earlier than the user expected. Therefore, a person with diabetes may not be able to take their medications on time.

Insulin pumps, such as the t:slim X2, are designed to automatically deliver insulin under the user’s skin at specific intervals and as needed. They take responsibility for controlling sugar levels so that the user can go about their day without having to stop and inject or be prone to hypo- or hyperglycemia.

If the pump shuts down without warning and sooner than the user expects, this may result in inadequate insulin delivery. As the FDA explained in the recall, can lead to hyperglycemia and even diabetic ketoacidosis – A life-threatening complication caused by the body’s inability to convert sugar into energy due to insulin deficiency.

Tandem Diabetes Care, the developer of the app and pump, sent an emergency message to all affected customers in March. It was recommended to update the app, closely monitor the pump’s battery level, and carry a spare dose of insulin.