FDA recalls faulty iOS app that injured hundreds of insulin pump users

The FDA issued a Class 1 recall of an iOS app that connects to insulin pumps due to a software glitch that causes the app to crash and restart automatically. This intermittent glitch drains the insulin pump’s battery and can lead to a premature shutdown. This shutdown can stop insulin delivery, posing a risk of hyperglycemia or diabetic ketoacidosis.

The recall highlights the challenges the FDA faces in keeping pace with technological innovation in healthcare. While criticism of the agency’s slow processes is common, recent efforts have demonstrated the agency’s commitment to strengthening its oversight of healthcare technology. This includes organizational changes in the Office of Strategic Partnerships and Technology Innovation. However, questions remain: Will the new bureaucratic measures be effective in addressing the FDA’s shortcomings?

As of April 15, 2024, there have been no reported deaths, but 224 individuals have reported injuries. A Class 1 recall, the most severe, is initiated when injuries or fatalities are possible, as per the FDA’s classification system.

The affected product, the t:slim X2 Insulin Pump Mobile App version 2.7, is manufactured by Tandem Diabetes Care. The company has issued a recall and advises customers to update to version 2.7.1 or later.

The recalled version of the app was distributed between February 12 and March 13, 2024, affecting 85,863 devices in the US.