Faulty glucose sensors: The US Food and Drug Administration has warned people to stop using certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose monitor sensors after Abbott Diabetes Care reported that the devices may be linked to 7 deaths and hundreds of injuries worldwide.
According to the FDA, some sensors from a specific production line may produce incorrect low glucose readings. If the falsely low readings persist, people with diabetes could make risky treatment decisions, such as eating excessive carbohydrates or skipping or delaying insulin doses, which the agency said could lead to serious harm.
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Abbott said the issue affects about three million sensors in the US, with roughly half already in use or expired. As of November 14, the company had received 736 reports of serious adverse events globally, including 57 in the US, and seven deaths, none of which occurred in the United States. Abbott said it has identified and resolved the manufacturing issue and has notified customers.
The FDA advised users to stop using affected sensors and discard them, and to check their device information to confirm whether they are part of the impacted lots. The affected models include FreeStyle Libre 3 and Libre 3 Plus sensors, each with its own model numbers and device identifiers. Abbott is offering replacements through its online checking portal, and said no other FreeStyle Libre products, readers or apps are impacted.