The U.S. Food and Drug Administration has issued a warning regarding certain glucose monitor sensors manufactured by Abbott Diabetes Care. The agency's alert follows reports linking these devices to seven deaths and over 700 injuries. The affected models, FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors, may provide inaccurate low glucose readings, according to FDA officials. These incorrect readings can lead individuals with diabetes to make poor treatment choices, such as consuming excessive carbohydrates or delaying insulin doses. The FDA stated, "These decisions may pose serious health risks, including potential injury or death." These sensors measure glucose levels in interstitial fluid just beneath the skin, providing real-time blood sugar readings. The data is transmitted wirelessly to a connected device or smartphone. The warning impacts approximately three million sensors in the U.S. from a specific production line, with Abbott noting that about half of these devices have either expired or been used. As of November 14, Abbott reported seven deaths globally and 736 serious adverse events related to these sensors. In the U.S., there have been no reported deaths, but 57 injuries have been documented. Abbott has reached out to all customers regarding the issue and has confirmed that the problem in the affected production lot has been identified and resolved. The FDA advises consumers to stop using the affected sensors and to dispose of them. The specific models involved include FreeStyle Libre 3 sensors with model numbers 72080-01 and unique device identifiers 00357599818005 and 00357599819002. The FreeStyle Libre 3 Plus sensors affected have model numbers 78768-01 and 78769-01, with unique device identifiers 00357599844011 and 00357599843014. Consumers can check if their sensors are impacted and request replacements through Abbott's channels. No other FreeStyle Libre products are implicated in this warning.
FDA Warns of Faulty Glucose Monitors Linked to Deaths
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