FDA recalls iOS app software that injured over 200 insulin pump users

At least 224 people with diabetes have reported injuries linked to a defective iOS app that caused their insulin pumps to shut down prematurely, according to the US 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 iOS t:connect mobile app, which is used in conjunction with the company’s t:slim X2 insulin pump. Specifically, the recall relates to a software issue that can cause the app to repeatedly crash and relaunch, resulting in the pump’s battery being drained by excessive Bluetooth communication.

This battery drain can cause the pump to shut down “earlier than typically expected” according to Tandem, though the pump will notify users of an imminent shutdown via an alarm and low-power alert. The company has notified customers to update the mobile app to version 2.7.1 or later, which should fix the defective software.

While no physical recall is taking place, the FDA has identified this as a “Class I” recall — the most serious type, as it relates to issues with products that can potentially cause serious injuries or death.

“Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia,” Tandem warned in its letter to customers in March. “In severe cases of hyperglycemia due to a prolonged period of no insulin delivery, the user may experience diabetic ketoacidosis and may require hospitalization or intervention from a medical professional.”

No deaths linked to the issues have been reported as of April 15th. Tandem is encouraging pump users to take particular care when they sleep as it’s easier to miss battery depletion warnings, and is asking impacted customers to confirm they have been notified of the recall via this online form. For any other questions or concerns about the insulin pump recall, customers should contact Tandem Diabetes Care directly.