FDA warns faulty glucose monitors are linked to multiple deaths and hundreds of injuries

"The U.S. Food and Drug Administration is warning people to stop using certain types of glucose monitor sensors after the company that makes them, Abbott Diabetes Care, said the devices were linked to seven deaths and more than 700 injuries.Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may provide incorrect low glucose readings, FDA officials said this week."

"The warning affects about three million sensors in the U.S. from a single production line, Abbott officials said in a statement. About half those devices have expired or been used, the company added. As of Nov. 14, the company reported seven deaths worldwide and 736 serious adverse events. No deaths occurred in the U.S., where 57 injuries were reported.Abbott has notified all customers of the problem."

The FDA warns that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may report incorrect low glucose readings, which can prompt dangerous treatment decisions such as overconsuming carbohydrates or delaying insulin. Abbott identified the issue in products from one production line and reported seven deaths worldwide and 736 serious adverse events, with 57 injuries in the U.S. About three million sensors are potentially affected, though roughly half are expired or used. Abbott has notified customers, said it resolved the production-line issue, and directs people to www.FreeStyleCheck.com to check devices and request replacements.

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