(NewsNation) — The U.S. Food and Drug Administration has issued a recall correction for an Apple iOS app used with an insulin pump that has caused at least 224 injuries after draining the pump’s battery and causing it to shut off early.
Tandem Diabetes Care, Inc. is recalling version 2.7 of the t:connect mobile app that pairs with the t:slim X2 insulin pump with Control IQ technology.
The software may cause the app to crash and automatically relaunch intermittently, which leads to excessive Bluetooth communication that may drain the pump’s battery sooner than expected, according to the FDA’s notice.
When the pump shuts down, it stops insulin delivery. That could lead to hyperglycemia or diabetic ketoacidosis — a potentially life-threatening condition caused by high blood sugar and lack of insulin.
Impacted users and health care providers should update the app to version 2.7.1 or later and monitor their pump battery level closely.
The FDA recommends people with diabetes always carry backup supplies for insulin delivery in case of pump failure.