Abbott has launched an effort to replace some of its FreeStyle Libre 3 continuous glucose monitors—following reports of hundreds of injuries and seven deaths worldwide—after some sensors showed they may provide incorrect readings that could prompt users to skip insulin doses.
The company said it has traced back the issue to a manufacturing defect linked to a single production line. However, that still amounts to about 3 million Libre 3 and Libre 3 Plus CGMs distributed within the U.S.—though about half are expected to have been used by now or are past their expiration date.
Abbott said it has received reports of 736 severe complications potentially associated with the problem, including 57 in the U.S., and seven deaths located outside of the country.
All users are urged to visit the company’s website to confirm whether their sensor is affected and receive a replacement at no charge if necessary.
Abbott also recommended that users double-check their readings with a separate blood glucose meter, or with the meter built into the Libre 3 reader, when considering their insulin doses if the sensor’s levels do not match up with their symptoms or expectations.
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In its notice, the company said that the root manufacturing issue has been resolved and that its multiple production lines are expected to be able to keep up the supply of the CGM going forward.
No other Libre family sensors, readers or smartphone apps are impacted by the urgent medical device correction effort, which has not yet received a formal recall designation from the FDA. The company said it has also alerted international regulatory authorities to the issue.
According to Abbott, incorrect low glucose readings over an extended period of time may lead to the wrong treatment decisions, including excessive carbohydrate intake as well as delayed insulin doses. That can pose serious health risks, including death, as well as less severe complications.
Abbott previously launched a recall and replacement effort for the FreeStyle Libre 3 in July of last year, after three lots of sensors demonstrated they could deliver erroneously high glucose readings. The company estimated that the effort only affected fewer than 1% of users within the U.S.