As many as 224 or more people have suffered injuries after a glitchy iPhone app called “t:connect” drained the battery on its “t:slim” X2 insulin pump, causing the pump to fail to deliver insulin, according to a Gizmodo report.
The FDA issued a Class I recall of the app on Wednesday, according to an FDA press release, which is the most severe type of recall issued by the agency.
Reason for Recall
Tandem Diabetes Care, Inc. is recalling version 2.7 (released February 12, 2024 on the Apple iOS platform) of the t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology by correction. 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.
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.
The recall includes 85,863 devices, says the FDA. Consumers are being warned to closely monitor the battery level of their insulin pumps, “to ensure the pump is at or near full charge before going to sleep to help prevent pump shutdown.”
The app’s battery issues reportedly happened most frequently between February 12, 2024, to March 13, when an update was released that appears to have fixed the issue. Users are being urged to update the version of the mobile app to version 2.7.1 or later. Users can find the app version by tapping the “Setting” icon and then tapping “About.”
The makers of the pump and app, Tandem Diabetes Care Inc., sent notices to customers in late March. U.S.-based customers who have questions about the pump and its app should contact the company directly at (877) 801-6901.
(Image credit: Tandem Diabetes Care, Inc.)