FDA Recalls iOS App Software That Injured More Than 200 Insulin Pump Users

At least 224 people with diabetes have reported injuries related to a faulty iOS app that caused their insulin pumps to shut down prematurely, according to the U.S. Food and Drug Administration (FDA).

On Wednesday, the agency announced that California-based medical device manufacturer Tandem Diabetes Care has issued a recall for version 2.7 of the t:connect iOS mobile app, which is used in conjunction with the company’s t:slim X2 insulin pump . Specifically, the recall is related to a software issue that can cause the app to crash and restart repeatedly, resulting in the pump’s battery draining from excessive Bluetooth communication.

This battery drain can cause the pump to shut down “sooner than normally expected,” according to Tandem, although the pump notifies users of an impending shutdown via a low-power alarm and alert. The company has notified customers to update the mobile app to version 2.7.1 or later, which should fix the faulty software.

Although no physical recall is occurring, the FDA has identified this as a “Class I” recall – the most serious type, as it relates to problems with products that can cause serious injury or death.

“Shutting down the pump will cause insulin administration to be suspended, which may lead to underadministration of insulin and may result in hyperglycemia, including severe hyperglycemia,” Tandem warned in its report. letter to customers in March. “In severe cases of hyperglycemia due to a prolonged period without insulin administration, the user may experience diabetic ketoacidosis and may require hospitalization or intervention by a medical professional.”

No deaths linked to the Troubles had been reported as of April 15. Tandem is encouraging users of the pumps to take special care when sleeping, as it is easier to ignore battery depletion warnings, and is asking affected customers to confirm they have been notified about the recall. through this online form. For any other questions or concerns about the insulin pump recall, customers should contact Tandem care for diabetes directly.