The U.S. Food and Drug Administration (FDA) has issued a significant alert regarding two glucose monitor sensors from Abbott Diabetes Care, which have been linked to serious health risks, including fatalities. The FDA’s warning highlights that the affected devices, the FreeStyle Libre 3 and FreeStyle Libre 3 Plus, have been malfunctioning and providing “incorrect low glucose readings.” As of November 14, 2023, Abbott has reported a troubling total of 736 serious injuries and seven deaths associated with these devices.
In a recent announcement, the FDA stated that Abbott had acknowledged a manufacturing issue that affects these sensors. Specifically, the company noted that more than 3 million units could be impacted. These glucose monitors are essential for individuals aged four and older living with diabetes, helping them manage their glucose levels effectively.
The FDA emphasized that undetected incorrect low glucose readings can lead to dangerous treatment decisions. Patients might mistakenly consume excessive carbohydrates or, conversely, delay or skip insulin doses. Such actions can result in severe health consequences, including potential injury or death, or less serious complications.
Abbott has confirmed it has “identified and resolved the cause of the issue” affecting the sensors and stated that production is ongoing for replacements and new orders. The company has advised consumers to rely on a blood glucose meter or the built-in meter within the FreeStyle Libre 3 reader when sensor readings do not align with their symptoms or expectations.
In a statement to the public, Abbott explained its approach to managing the recall. “We’ve contacted customers to make them aware and provide support,” the company noted. They also directed consumers to visit www.FreeStyleCheck.com to determine if their sensors are potentially affected and to request replacements at no cost. Abbott clarified that no other Libre products are impacted by this recall.
The specific model numbers and unique device identifiers for the affected sensors are as follows:
– **FreeStyle Libre 3 Sensor Model Numbers:** 72081-01, 72080-01
**Unique Device Identifiers:** 00357599818005, 00357599819002
– **FreeStyle Libre 3 Plus Sensor Model Numbers:** 78768-01, 78769-01
**Unique Device Identifiers:** 00357599844011, 00357599843014
Customers can find the serial number for their devices within the app or the reader, as well as on the label at the bottom of the sensor or carton. A comprehensive list of affected lot numbers can be accessed through Abbott’s official resources.
The FDA is urging anyone who has experienced adverse reactions or problems with their glucose monitors to reach out to Abbott Diabetes Care at 1-833-815-4273. Additionally, both healthcare professionals and consumers are encouraged to report any adverse effects to the FDA’s MedWatch program, which is responsible for safety information and adverse event reporting.
As the situation develops, Abbott remains committed to ensuring the safety and well-being of its customers, reinforcing the importance of using reliable glucose monitoring methods to manage diabetes effectively.