According to the FDA, Tandem Diabetes Care, Inc. issued a correction update earlier this month regarding an initial recall issued in March pertaining to the Apple iOS t:connect Mobile App software used with their t:slim X2 insulin pump with Control-IQ technology. The correction does not involve a recall of the t:slim X2 Insulin Pump device but instead pertains to the software used in conjunction with the pump.
On March 18, 2024, Tandem Diabetes Care, Inc. recalled version 2.7 of the Apple iOS t:connect Mobile App intended for use with the t:slim X2 insulin pump with Control-IQ technology. The company had received word that patients and medical professionals were experiencing rapid battery depletion when using version 2.7 of the mobile app due to a software problem. In response, Tandem Diabetes Care, Inc. directed all users to update their Apple iOS t:connect Mobile App to the 2.7.1 version.
On August 9, 2024, Tandem Diabetes Care, Inc. issued an “Urgent Medical Devise Correction Update,” clarifying that users have continued to experience rapid battery depletion when using version 2.7.1 of the Apple iOS t:connect Mobile App with the t:slim X2 Insulin Pump device. The company now directs that all users in the United States update to version 2.8.2 of the Apple iOS t:connect mobile app to resolve the issue with rapid battery depletion.
Use of an older version of the Apple iOS t:connect mobile app with the t:slim X2 insulin pump with Control-IQ technology could result in serious injury or death. The initial recall explains that a software problem in versions 2.7 and 2.7.1 causes the app to crash and relaunch, which causes rapid depletion of the pump battery. Pump battery failure can then result in disruption to insulin delivery. This disruption can cause hyperglycemia or even diabetic ketoacidocis in users. No fatalities have been reported thus far, but Tandem Diabetes Care, Inc. received 224 reported injuries as of April, 2024, in connection to use of an older version of the mobile app.
Apart from this update, Tandem Diabetes Care, Inc. encourages users to follow the instructions listed in the User Guide for the t:slim X2 insulin pump with Control-IQ technology. Users should also be sure to carefully motor battery levels for the pump, to keep the pump fully charged, and to ensure a back-up method for insulin administration in case of pump failure.
Anyone with questions about this Urgent Medical Device Correction Update can contact the Tandem Diabetes Care Technical Support Team at (877) 801-6901.
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