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Regulators Warn Against Use of Certain Abbott Glucose Sensors After Reports of Deaths and Injuries
US health authorities have issued an alert urging people to stop using specific models of Abbott Diabetes Care’s glucose monitoring sensors after the company linked the devices to seven deaths and hundreds of serious injuries around the world.
The US Food and Drug Administration (FDA) said this week that select batches of the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may report falsely low glucose readings. Incorrect readings over time can prompt people with diabetes to make unsafe treatment choices, including taking excessive carbohydrates or delaying necessary insulin doses.
In its notice, the FDA said such decisions could pose major health risks and may lead to severe injury or death.
The sensors track glucose in the fluid beneath the skin, providing continuous updates that are transmitted to a user’s phone or reader. Abbott said the alert covers around three million sensors distributed in the United States, all from a single production line. Around half of those units have either been used or are past their expiry date.
FreeStyle Libre 3 was approved for use in Europe in 2020, and the sensors are sold in several major markets including Germany, Spain, Italy, France, the Netherlands and the UK. As of 14 November, Abbott reported seven deaths and 736 serious incidents tied to the affected sensors worldwide.
The company said it has contacted all customers and healthcare partners about the issue and confirmed that it has identified and corrected the fault in the production batch linked to the problem.
The FDA is advising users to dispose of affected sensors immediately. Impacted devices include FreeStyle Libre 3 sensors with model number 72080-01 and unique device identifiers 00357599818005 and 00357599819002. The alert also covers FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01 with identifiers 00357599844011 and 00357599843014.
Abbott has directed consumers to a dedicated website, FreeStyleCheck.com, where they can check whether their device is part of the affected lot and request a replacement at no charge. The company stressed that no other FreeStyle Libre products are involved in the warning.
Regulators said the alert will remain in place until they are satisfied that all potentially problematic sensors have been removed from circulation and replaced with updated units.
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