Dive Brief:
- Tandem Diabetes Care warned that some people are still experiencing problems with an iPhone app rapidly depleting their insulin pump battery, despite a recent software update to fix the issue, according to a Monday notice from the company.
- Tandem began a recall in March of its t:connect iPhone app, which allows people to view blood sugar data from the t:slim X2 insulin pump and enter bolus doses. At the time, the diabetes tech firm received reports that users’ pump batteries were depleting faster than usual.
- The company issued a software update that month to fix the problem, but it is still receiving reports of battery problems. Tandem said it has received 107 confirmed adverse events related to the recall after the latest update and two confirmed injuries requiring hospitalization due to the pump shutdown. The Food and Drug Administration also shared Tandem’s alert on Monday.
Dive Insight:
In a notice sent to customers on Aug. 9, Tandem said it plans to issue another software update to fix any remaining problems. People with versions 2.7 or 2.7.1 of the t:connect app on Apple’s iOS mobile operating system may experience the problem.
The app may “intermittently retrieve significantly more data than is necessary from the pump,” Tandem said, causing it to crash and relaunch. This can lead to excessive Bluetooth communication that may drain the pump’s battery and cause it to shut down sooner than expected.
An unexpected shutdown could result in under-delivery of insulin and hyperglycemia for people with diabetes. Users may be at a higher risk if the battery depletion happens at night, the company said.
For users with an affected pump, Tandem recommended charging it for 10 to 15 minutes every day and ensuring the pump is at or near full charge before going to sleep. The company also said to charge the pump “as soon as possible” after a low-battery alert.
Prior to the latest update, Tandem received about 224 injury reports in two months for version 2.7 of the app. The March recall affected nearly 86,000 devices in the U.S.