FDA Issues Insulin Pump App Recall After More Than 200 Injured

The FDA has issued a Class 1 recall of a popular insulin pump app after it was discovered that there was a software issue that caused the app to crash.

According to USA Today, this crash subsequently drained the battery of the insulin pump and caused more than 200 injuries in patients, though no deaths have been reported.

In its official announcement, the FDA has announced that this recall is considered a Class 1 recall — the most serious type of recall — because this software crash has the potential to cause serious injury or death to those who use it. However, the FDA also made clear that this Class 1 recall was a product correction and not a removal of the product from the market.

The correction was first initiated by the app manufacturer back in March.

The affected insulin pump app is the t:connect (version 2.7), and the Apple software works with the t:slim X2 insulin pump with Control-IQ technology. In addition to controlling the insulin pump, the app can also be used to monitor the pump information and see if it’s working.

The malfunction of the app causes the pump to shut down, leading to an under-delivery of insulin and causing hyperglycemia and diabetic ketoacidosis. If left uncorrected, hyperglycemia and diabetic ketoacidosis can cause coma and even death in patients.

More than 85,000 devices have been recalled by the FDA as of this writing, and 224 people have been hospitalized with injuries. There have, however, been no deaths reported.

Customers are required to fill out an online form acknowledging receipt of a notice to update the insulin pump app and to continue using the pump as prescribed by their physician while periodically monitoring the app for system alerts and alarms.

Additionally, customers are being asked to monitor the pump’s battery level and ensure it’s either fully charged or close to fully charged before turning in for the night. For best results, the FDA recommends carrying insulin backup supplies in the event of pump failure.

Anyone with any further questions about the insulin pump app should call the Tandem Diabetes Care Technical Support Team at 877-801-6901.