FDA Recalls Defective iOS App That Injured Over 200 Insulin Pump Users

| Updated on June 25, 2024
FDA Recalls Defective ios

Recently more than 200 people with diabetes have reported sustaining injuries due to a defective iOS app that causes their insulin pumps to shut down prematurely.

On Wednesday, the FDA announced that a 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 with the company’s t:slim X2 Insulin Pump.

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. The battery drain caused the pumps to shut down before they were expected to. However, the pump does notify users before it stops working with an alarm and low power alert.

The company has commented that updating the app to version 2.7.1 or later would have fixed the issue.

There have been no physical recalls as of yet, and 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.”

At the time of writing this article, no deaths linked to the issue have been reported but Tandem is encouraging the users to be very careful when they sleep, as it is easier to miss the battery-low warnings.

Reena Choudhary