The U.S. Food and Drug Administration has issued a warning urging individuals to discontinue the use of certain glucose monitor sensors manufactured by Abbott Diabetes Care. This caution comes after Abbott revealed that these devices were associated with seven deaths and more than 700 injuries.
The specific sensors in question are the FreeStyle Libre 3 and FreeStyle Libre 3 Plus, which have been found to potentially provide inaccurate low glucose readings. Prolonged reliance on these erroneous readings could prompt individuals with diabetes to make harmful treatment decisions, such as consuming excessive carbohydrates or delaying insulin doses.
The sensors function by measuring glucose levels in the fluid just beneath the skin, offering real-time blood sugar measurements. The data collected by the sensor is transmitted wirelessly to a compatible device or smartphone.
Abbott has disclosed that approximately three million sensors from a single production line are impacted by this warning in the U.S. However, the company stated that approximately half of these devices have already expired or been used. As of November 14, Abbott has reported seven deaths globally and 736 serious adverse events. Notably, no fatalities have occurred in the U.S., with 57 injuries being reported.
The company has taken proactive measures by notifying all customers about the issue and confirming that the problem has been identified and rectified in the affected production lot. The FDA advises individuals to discontinue the use of the affected sensors and dispose of them immediately.
The problematic sensors include FreeStyle Libre 3 sensors with model numbers 72080-01 and unique device identifiers 00357599818005 and 00357599819002. Additionally, FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01, along with unique device identifiers 00357599844011 and 00357599843014, are also affected.
Individuals can visit the website www.FreeStyleCheck.com to determine if their sensors are potentially impacted and request a replacement from Abbott. It’s important to note that no other products in the FreeStyle Libre line are affected by this warning.
In conclusion, it is crucial for individuals using these glucose monitor sensors to adhere to the FDA’s advisory and take the necessary steps to ensure their safety and well-being. Stay informed and prioritize your health when it comes to managing diabetes effectively.
