Version 2.7 of the Apple iOS t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology has been recalled, according to the FDA.
The t:connect app “works with the t:slim X2 insulin pump with Control-IQ technology,” and 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 pump itself is meant to “deliver insulin under the skin…at set and variable rates, for the management of diabetes in persons requiring insulin.” The Control-IQ technology can then “adjust insulin delivery based on glucose readings, both current and predicted, and can give extra insulin as needed.”
The reason for the recall “is due to an issue with the software that may cause the mobile app to crash and be automatically relaunched by the iOS operating system. 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.” If this happens, insulin delivery can be suspended, “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.” As of April 15, 224 injuries have been reported, none of which resulted in death.
Tandem Diabetes Care, Inc., sent all affected customers an Urgent Medical Device Correction, requesting customers to “update the mobile app to version 2.7.1 or later, available in the Apple App Store,” and then “monitor pump battery level closely to ensure the pump is at or near full charge before going to sleep to help prevent pump shutdown.”
