Health Canada issued an alert stating that certain FreeStyle Libre 3 glucose monitor sensors may provide inaccurate low glucose readings. Abbott Diabetes Care recalled specific types of FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensor kits, which have been associated with seven deaths and over 700 injuries. The 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 checking the sensor serial number on the official website to determine if the product is affected. Users were advised to immediately discontinue the use of the sensor, dispose of the affected device, and request a replacement. The U.S. Food and Drug Administration also warned the public to stop using the recalled glucose monitor sensors.
These sensors measure glucose levels in the fluid below the skin to provide real-time blood glucose measurements. Around three million sensors in the U.S. from a specific production line were affected. Abbott reported that about half of the devices have either expired or been used. As of the latest update, there have been seven deaths globally and 736 severe adverse events, with no deaths reported in the U.S. but 57 injuries.
Abbott stated that they have addressed the issue in the affected production lot and have notified all customers about the problem. The FDA recommended discarding the affected sensors immediately. The recall involves FreeStyle Libre 3 sensors with specific model numbers and unique device identifiers. Individuals can verify if their sensors are impacted and request replacements on the official website. Abbott assured that no other FreeStyle Libre products are affected by the recall.