Dive Brief:
- Tandem Diabetes Care is recalling a version of its t:connect app for iPhone because of a fault that could drain insulin pump batteries, the Food and Drug Administration said Wednesday.
- After updating the app in February, Tandem received 224 injury reports in about two months. The reports related to an issue that caused the app to crash and relaunch, resulting in excessive use of Bluetooth and potentially draining the battery of the connected insulin pump.
- The FDA categorized the event as a Class I recall because of the life-threatening potential for pumps to deliver too little insulin. Tandem corrected the fault in an app update in March.
Dive Insight:
The t:connect mobile app works with Tandem’s t:slim X2 insulin pump. Using the app, people can deliver fast-acting insulin and view data from their pumps.
In February, Tandem launched version 2.7 of the app. Shortly after the update, Tandem began seeing an increase in customer calls reporting that their pump’s battery was depleting faster than anticipated, a company spokesperson wrote in an email.
Upgrading to version 2.7 caused problems for some users. The FDA said a software issue “may cause the mobile app to crash and be automatically relaunched by the iOS operating system.” The cycle of crashing and relaunching “intermittently repeats,” the FDA said, and leads to excessive Bluetooth communication.
The increase in communication between the app and t:slim X2 can cause the pump battery to drain. The pump could power down sooner than expected, leading to “an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis,” the agency said. Diabetic ketoacidosis is a potentially life-threatening condition caused by high blood sugars and lack of insulin.
Tandem is correcting more than 85,000 apps in the U.S. The company released version 2.71 of the app, which it said featured overall performance updates, on March 18. Around one week after updating the app, Tandem asked all affected customers to download version 2.71.
So far, more than 98% of affected users have updated their devices with the new version, the company spokesperson wrote, “and we continue to make every effort to contact anyone who has not yet updated their software to the new version.”