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FDA warns of short battery life in app-reliant insulin pumps

  • FDA issued a recall correction for insulin pump that connects to app
  • A software issue may cause the pump to prematurely shut down
  • The problem has caused at least 224 injuries but no deaths

Updated:
FILE - A sign for the Food and Drug Administration is displayed outside their offices in Silver Spring, Md., on Dec. 10, 2020. According to research published Sunday, April 7, 2024, in the Journal of the American Medical Association, most cancer drugs granted accelerated approval by the FDA, meant to give patients early access to promising drugs, do not demonstrate such benefits within five years. (AP Photo/Manuel Balce Ceneta, File)

FILE – A sign for the Food and Drug Administration is displayed outside their offices in Silver Spring, Md., on Dec. 10, 2020. According to research published Sunday, April 7, 2024, in the Journal of the American Medical Association, most cancer drugs granted accelerated approval by the FDA, meant to give patients early access to promising drugs, do not demonstrate such benefits within five years. (AP Photo/Manuel Balce Ceneta, File)

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(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.

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