The U.S. Food and Drug Administration (FDA) has issued a warning regarding specific glucose monitor sensors manufactured by Abbott Diabetes Care. This alert follows reports linking these devices to seven deaths and over 700 injuries globally. The affected products, the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors, may provide inaccurate low glucose readings, potentially leading individuals with diabetes to make harmful treatment decisions.
FDA officials stated that prolonged exposure to incorrect low readings could result in serious health risks, including severe injury or even death. The sensors measure glucose levels in interstitial fluid just beneath the skin, transmitting real-time data wirelessly to a connected device or smartphone.
As per Abbott’s statement, approximately three million sensors from a single production line in the U.S. are involved in this recall, with an estimated half of these devices already expired or used. As of November 14, 2023, Abbott confirmed seven deaths worldwide and a total of 736 serious adverse events linked to these sensors. Importantly, no fatalities were reported in the United States, where 57 injuries related to the issue have been documented.
Details on Affected Products and Safety Measures
Abbott has proactively notified all customers regarding the potential risks associated with the affected sensors. The company has identified the cause of the inaccuracies and has taken steps to resolve the issue within the implicated production lot. Consumers are advised to discontinue use of the affected sensors immediately and to dispose of them properly.
The specific model numbers affected include the FreeStyle Libre 3 sensors with model numbers 72080-01 and unique device identifiers 00357599818005 and 00357599819002. Additionally, the FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01, and unique identifiers 00357599844011 and 00357599843014 are also implicated.
For consumers seeking further information, Abbott has launched a website at www.FreeStyleCheck.com, where users can verify if their sensors are among those affected and request replacements. Importantly, Abbott clarified that no other FreeStyle Libre products are impacted by this warning.
The FDA continues to emphasize the importance of accurate glucose monitoring for those living with diabetes. The agency advises all users of the affected devices to consult with healthcare professionals regarding their treatment plans, especially those who may have relied on the inaccurate readings from these sensors.
This situation highlights the critical need for vigilance in medical device safety and the ongoing responsibility of manufacturers to ensure their products meet rigorous health standards.
