The United States Food and Drug Administration (FDA) has issued a critical public warning, urging individuals to immediately discontinue the use of specific models of a widely used continuous glucose monitoring system. This urgent alert comes after the manufacturer, Abbott Diabetes Care, reported that the devices are associated with seven fatalities and more than 700 injuries globally.
What is the Core Problem with the Sensors?
According to the FDA's statement released this week, certain lots of the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may be providing dangerously inaccurate readings. The primary fault identified is that these sensors can display incorrectly low glucose levels. For people managing diabetes, such faulty data over a prolonged period can lead to catastrophic treatment decisions.
Patients relying on this erroneous information might consume excessive carbohydrates to counter a perceived low or, more perilously, skip or delay their essential insulin doses. "These decisions may pose serious health risks, including potential injury or death," the FDA explicitly stated in its official safety communication.
Scale of the Recall and Global Impact
Abbott officials clarified that the warning impacts approximately three million sensors distributed within the United States, all originating from a single production line. The company estimates that roughly half of these devices have already expired or been used by patients.
As of the latest report dated November 14, the global toll stands at seven confirmed deaths and 736 serious adverse events linked to the sensor malfunction. While no deaths have been reported in the U.S., 57 injuries have been documented there. Abbott has stated that it has notified all its customers about the critical issue and has identified and resolved the manufacturing flaw in the affected production batch.
How to Identify and Replace Affected Sensors
The FDA's directive is clear: individuals should stop using and discard the affected sensors immediately. The specific models involved are:
- FreeStyle Libre 3 sensors with model number 72080-01 and Unique Device Identifiers (UDIs) 00357599818005 and 00357599819002.
- FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01 and UDIs 00357599844011 and 00357599843014.
Abbott has set up a dedicated online portal for users to verify if their sensor is from the problematic lots and to request a free replacement. Customers can visit www.FreeStyleCheck.com to perform this check. The company has assured that no other FreeStyle Libre products are involved in this safety alert.
Continuous glucose monitors (CGMs) like the FreeStyle Libre are small, wearable sensors that measure glucose levels in interstitial fluid just beneath the skin, sending real-time data wirelessly to a smartphone or dedicated reader. They are vital tools for millions with diabetes to manage their condition daily. This incident underscores the profound importance of device accuracy and robust post-market surveillance in medical technology.
