The Food and Drug Administration (FDA) in the United States has issued a Class I recall for an iOS app used in conjunction with insulin pumps.
The recalled t:connect mobile app is solely for for Version 2.7 of the t:connect mobile app, which works with the t:slim X2 insulin pump with Control-IQ technology.
According to the FDA:
Tandem Diabetes Care, the company behind the app, issued the recall because of an issue with the software that may result in the app’s crashing and automatically relaunching repeatedly.
This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected.
The t:connect mobile app can also be used as a method of viewing pump information and limited control of the pump through compatible smartphone models, operating systems and pump software versions.
The t:slim X2 insulin pump is intended to deliver insulin under the skin (subcutaneous delivery), at set and variable rates, for the management of diabetes in persons requiring insulin. It can connect securely with other devices like insulin dosing software.
The Control-IQ technology works with compatible continuous glucose monitors and pumps to adjust insulin delivery based on glucose readings, both current and predicted, and can give extra insulin as needed.
Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin.
There have been 224 reported injuries as of April 15, 2024 and no reports of death.
