Dive Brief:
- Abbott has issued a medical device correction for about 3 million Freestyle Libre 3 and 3 Plus sensors in the U.S. after determining that some sensors may provide incorrect low glucose readings, the company announced Monday.
- Abbott has received reports of 736 severe adverse events and seven deaths overall associated with the problem. In the U.S., 57 severe adverse events and no deaths were reported.
- The problem could lead to incorrect treatment decisions, such as people skipping or delaying insulin doses and excessive carbohydrate intake. Abbott said it has resolved the cause of the problem, which was related to one production line, and will replace any potentially affected sensors at no charge.
Dive Insight:
Abbott received Food and Drug Administration clearance for its Libre 3 continuous glucose monitor in 2022. The Libre 3 Plus version, which has a 15-day wear time and can be worn by younger children, was cleared by the FDA in 2023.
Of the approximately 3 million sensors affected by the correction, about half are estimated to have expired or been used.The FDA has not yet posted the correction in its recall database.
Abbott said it continues to produce Libre 3 and Libre 3 Plus sensors to fulfill replacements and new orders, and the company does not expect supply disruptions.
Abbott recalled its Libre 3 devices last year after finding a subset of the sensors may provide incorrect high glucose readings. At the time, a company spokesperson said the recall may affect less than 1% of Libre 3 users in the U.S.
Competitor Dexcom has also faced challenges with the company’s latest glucose sensor, with executives saying on its latest earnings call that they fixed a deployment problem with the G7 that started at the beginning of the year. Dexcom recalled its older G6 device earlier this month over a software problem that can cause the G6 app to terminate unexpectedly, requiring users to update the app to a new version.
