The FDA has issued an alert regarding incorrect low glucose readings from certain FreeStyle Libre 3 and 3 Plus glucose monitor sensors, leading to serious injuries and deaths. Abbott Diabetes Care has reported hundreds of injuries and deaths. Patients are advised to check their sensor serial numbers and discontinue use of affected sensors.
The Food and Drug Administration has issued an alert after certain FreeStyle Libre glucose monitor sensors are providing incorrect low glucose readings.As of Nov. 14, the FDA says Abbott Diabetes Care has reported 736 serious injuries, and seven deaths associated with some models of FreeStyle Libre 3 and FreeStyle Libre 3 Plus.
The FDA says if undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions may pose serious health risks, including potential injury or death, or other less serious complications. The FDA says Abbott Diabetes Care sent all affected customers a letter on Nov. 24.The affected models are:According to the FDA, FreeStyle Libre 3 readers and mobile apps are not impacted and no other Libre products or Abbott biowearables are impacted.The FDA says patients can determine if their current or unused sensor are affected by visiting www.freestylecheck.com and selecting "CONFIRM SENSOR SERIAL NUMBER." The serial number for the FreeStyle Libre 3 sensor or a FreeStyle Libre 3 Plus sensor can be found in the app or reader and also on the label on the bottom of the sensor applicator or carton.Patients should verify if their sensors are impacted and immediately discontinue use and dispose of the affected sensor.Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Abbott Diabetes Care at 1-833-815-4273 or www.freestyle.abbott/us-en/support/contact-us.html
FDA Freestyle Libre Glucose Monitor Diabetes Recall
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