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Recently, Abbott Diabetes Care posted an alert for a subset of its FreeStyle Libre 3 and Libre 3 Plus continuous glucose monitor (CGM) sensors. Internal testing revealed that some sensors manufactured on a single production line may provide inaccurate, low glucose readings—potentially leading patients to delay or skip necessary insulin doses. The alert affects approximately 3 million sensors in the United States; about half are estimated to have expired or already been used. Globally, Abbott has received 736 reports of serious adverse events (57 in the United States) and 7 deaths potentially linked to this issue.
Now what? According to the Food and Drug Administration, clinicians should inform patients using CGMs about the issue and have them check their device serial number on the manufacturer’s website (www.FreeStyleCheck.com). If they have a sensor noted in the alert, they should discontinue use immediately and dispose of it. The manufacturing issue has been resolved, and replacement sensors will be provided at no cost, according to Abbott.