Diving certificate:
- Tandem Diabetes Care warned that some people were still having problems with an iPhone app that quickly drained their insulin pump battery, even though the problem was recently fixed with a software update, according to a statement on Monday. Company announcement.
- tandem started a recall in March, its t:connect iPhone app, which allows users to view blood glucose data from the t:slim X2 insulin pump and enter bolus doses. At the time, the diabetes technology company received reports that users’ pump batteries were draining faster than usual.
- The company released a software update this month to fix the problem, but is still receiving reports of battery issues. Tandem said it has received 107 confirmed adverse events related to the recall since the latest update, as well as two confirmed injuries requiring hospitalization due to the pump shutdown. The Food and Drug Administration also shared Tandem’s Alert on Monday.
Diving insight:
In a Notification sent to customer On August 9, Tandem announced that it would release another software update to fix any remaining issues. Users running version 2.7 or 2.7.1 of the t:connect app on Apple’s iOS mobile operating system may experience the issue.
The app can “at times pull significantly more data from the pump than necessary,” Tandem said, which can lead to crashes and reboots. This can result in excessive Bluetooth communication, which can drain the pump’s battery and cause it to shut down sooner than expected.
An unexpected shutdown could lead to insulin deficiency and hyperglycemia in diabetics, and if the battery is drained at night, users may be at greater risk, the company said.
For users with an affected pump, Tandem recommends charging it for 10 to 15 minutes daily and making sure the pump is fully or nearly fully charged before bedtime. The company also recommends charging the pump “as soon as possible” after a low battery warning.
Before the latest update, Tandem received about 224 breach reports for version 2.7 of the app within two months. The March recall affected nearly 86,000 devices in the U.S.
