Dive Brief:
- Tandem Diabetes Care issued an urgent medical device correction for a software problem with its Mobi insulin pumps.
- The malfunction may cause insulin delivery to stop, causing high blood sugar if not addressed, the Food and Drug Administration said in a Wednesday recall notice.
- Tandem sent a letter to customers in October notifying them of the fault and instructing them to update their pump software as soon as possible. Tandem had reported four serious injuries related to the problem as of Nov. 4.
Dive Insight:
Tandem’s Mobi insulin pump received FDA clearance in 2023. The small, tubed pump is operated using a smartphone.
Tandem said the pump may malfunction by incorrectly detecting a motor issue. The malfunction stops insulin delivery, and halts communication between the pump and a continuous glucose monitor, as well as the Tandem Mobi mobile app. The problem could lead to severe hyperglycemia.
Users should update their pump software and be prepared with a backup method of insulin delivery, according to the FDA notice.
The FDA classified the recall as Class I, the most serious type of recall, and said more than 17,700 devices were affected, according to an enforcement report.
Tandem’s latest recall is one of several diabetes device safety problems noted by the FDA this year. Competitor Insulet recalled its Omnipod 5 insulin patch pumps in March over a problem with tears in certain devices’ internal tubing. The FDA also sent warning letters this year to Unomedical about a problem with leaking infusion sets and Beta Bionics over how the company handled complaints of severe low and high blood sugar associated with its automated insulin delivery system.
