The Food and Drug Administration has issued a statement following the Class I recall for an iOS app used in conjunction with insulin pumps after 224 injuries were reported.
The mobile app is version 2.7 of t:connect, which functions with the t:slim X2 insulin pump with Control-IQ technology. While the FDA says the recall is a correction rather than a product removal, more than 86,000 devices have already been recalled in the U.S.
According to the FDA, Tandem Diabetes Care, the company behind the app, issued the recall because of an issue with the software that may result in the app’s crashing and automatically relaunching repeatedly. That leads to excessive Bluetooth communication, which could drain the battery life of the insulin pump, causing it to shut down abruptly.
Such a shutdown could delay insulin delivery to the body and cause life-threatening injuries and conditions like hyperglycemia or diabetic ketoacidosis.
The FDA statement said Tandem Diabetes Care sent all affected users a letter asking them to update the software to version 2.7.1 or later, which is available for download in the Apple App Store. Customers are then to complete an online form confirming receipt of the notice and are expected to monitor the pump battery level closely at all times.
The FDA also encourages users to carry backup supplies for insulin delivery should pump failure persist.
Customers with any questions or concerns about the recall can reach Tandem Diabetes Care at (877) 801-6901.
