Abbott has issued a medical device correction for 3 million continuous glucose monitors, the company announced Nov. 24. Testing revealed that some Freestyle Libre 3 systems may provide incorrect low glucose readings—potentially leading to serious health complications for people with diabetes. Worldwide, there have been 736 reports of severe adverse events (57 in the U.S.) and seven deaths that may be linked to this issue.
Which Glucose Sensors Are Affected?
The incorrect readings have been associated with FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors. You can check if your sensor is affected by searching its serial number here. The correction does not impact the FreeStyle Libre 3 reader or app, or any other Libre products.
What You Should Do
If your FreeStyle Libre 3 sensor is affected, stop using it immediately. Request a free replacement from Abbott, and in the meantime, make treatment decisions using a blood glucose meter, the built-in meter in your FreeStyle Libre 3 Reader, or an unaffected sensor.
For more information, see the FAQs contained in Abbott’s announcement or contact Abbott Customer Service at 1-833-815-4273 or through live chat.
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