Health Canada has issued a warning regarding certain FreeStyle Libre 3 glucose monitor sensors that may provide inaccurate low glucose readings. Abbott Diabetes Care has initiated a recall for specific FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensor kits due to their association with seven fatalities and over 700 injuries.
Incorrect low glucose readings could potentially lead to improper treatment decisions for individuals with diabetes, such as consuming excessive carbohydrates or delaying insulin doses. Health Canada emphasized the importance of promptly identifying affected sensor kits by checking the serial number on the sensor and visiting the website www.freestylecheck.com for verification. If confirmed, users are advised to discontinue use, dispose of the faulty sensor, and request a replacement.
The U.S. Food and Drug Administration has also cautioned against the use of these recalled glucose monitor sensors. These sensors function by measuring glucose levels in the fluid just below the skin to provide real-time blood sugar readings transmitted wirelessly to a compatible device.
In the U.S., approximately three million sensors from a single production line are affected by the warning, with half of them either expired or utilized. Abbott has reported seven global deaths and 736 serious adverse events related to the affected sensors as of November 14. While no deaths have been reported in the U.S., there have been 57 cases of injuries.
Abbott has notified all customers of the issue and has rectified the problem in the affected production batch. Consumers are advised by the FDA to cease using the impacted sensors and discard them. The specific FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensor models affected by the recall have been identified by Abbott, and individuals can check their devices for potential impact and request replacements through www.FreeStyleCheck.com. Other FreeStyle Libre products are not part of the recall.
