Feb 4 (Reuters) – Medical device maker Abbott Laboratories has reported 860 serious injuries linked to the recall of some of its glucose monitoring sensors, the U.S. Food and Drug Administration said on Wednesday, citing company data as of January 7. Last November, while initiating a medical device correction in the U.S., Abbott reported 736 […]
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US FDA says injuries from Abbott’s recalled glucose sensors reach 860
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Feb 4 (Reuters) – Medical device maker Abbott Laboratories has reported 860 serious injuries linked to the recall of some of its glucose monitoring sensors, the U.S. Food and Drug Administration said on Wednesday, citing company data as of January 7.
Last November, while initiating a medical device correction in the U.S., Abbott reported 736 severe adverse events and seven deaths potentially linked to certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors.
The U.S. Food and Drug Administration issued an early alert on December 2 and classified this as a Class I recall, the most serious type, on January 14, a company spokesperson told Reuters.
Abbott said the sensors can provide incorrect glucose readings over extended periods, which could lead to users making dangerous treatment decisions, including eating excessive carbohydrates along with skipping or delaying insulin doses, potentially leading to serious health risks.
The company said it has identified and resolved the cause of the issue, which relates to one production line among several that make Libre 3 and Libre 3 Plus sensors.
(Reporting by Kamal Choudhury, Christy Santhosh and Siddhi Mahatole in Bengaluru; Editing by Shilpi Majumdar and Vijay Kishore)