Over 200 individuals have been injured due to a glitch in the t:connect iPhone app that drained the batteries of the accompanying insulin pump, t:slim X2. The FDA has issued a Class I recall for the app, the most serious type of recall, citing a software issue that causes the app to crash and excessively communicate via Bluetooth, leading to battery drain and potential pump shutdown.

The recall affects 85,863 devices, with consumers advised to monitor pump battery levels closely, especially before bedtime, to prevent unexpected shutdowns. The battery drain issue occurred primarily between February 12 to March 13, but an update to version 2.7.1 or later seems to resolve the problem.

A pump shutdown can interrupt insulin delivery, potentially causing hyperglycemia or even diabetic ketoacidosis, a life-threatening condition. Tandem Diabetes Care Inc., the manufacturer of the pump and app, has notified customers and provided guidance on how to address any concerns.

For those affected by this issue, updating the app to the latest version is crucial to ensure the proper functioning of the insulin pump and prevent any health risks associated with insulin delivery disruptions.