KPNX 12 NewsWASHINGTON — Malfunctioning glucose sensors used by millions of people with diabetes have been tied to more than 700 serious injuries and seven deaths worldwide, according to new information released by Abbott Diabetes Care and the U.S. Food and Drug Administration.
The FDA issued an early safety alert Dec. 2 after Abbott disclosed the issue in a public statement and direct customer letter on Nov. 24.
The company has initiated what it calls a “medical device correction” affecting certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring (CGM) sensors.
The alert was published before the FDA could determine whether the situation warrants a formal recall, which prompted the agency to issue an early safety alert as it considers stronger action.
As of Nov. 14, Ab
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