False Low Glucose Readings Prompt FreeStyle Libre 3 Device Correction

Credit: 451 Alliance

Abbott has issued a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring (CGM) sensors in the United States after discovering that some sensors may provide incorrect low glucose readings. These false low readings were identified during Abbott’s internal testing and are linked to one specific production line. Abbott reports that the manufacturing issue has now been identified and fixed, and production of new sensors continues.

This action affects about 3 million sensors made on that production line. Based on Abbott’s estimates, roughly half of these sensors have already been used or have expired. While Abbott emphasizes that the problem involves only a subset of Libre 3 and Libre 3 Plus sensors, the potential health impact is serious: Relying on abnormally low sensor readings could lead people with diabetes to make incorrect treatment decisions, such as consuming unnecessary carbohydrates or reducing/skipping insulin doses. Over time, decisions like these can increase the risk for complications, severe hyperglycemia or life-threatening consequences.

Globally, Abbott has received 736 severe adverse event reports and seven death reports potentially linked to this issue. None of these deaths occurred in the United States. In the U.S., 57 severe adverse events have been reported.

To help consumers identify whether their sensors are impacted, Abbott has created a dedicated website. Anyone using Libre 3 or Libre 3 Plus sensors should go there to check their sensor’s serial number. If the sensor is identified as part of the correction, Abbott will replace it at no cost.

If someone is currently wearing an affected sensor, they should stop using it immediately, dispose of it and switch to another method of glucose monitoring. Abbott recommends using a blood glucose meter or the built-in meter on the Libre 3 reader whenever a CGM reading doesn’t match how someone feels or when symptoms and numbers don’t align.

Importantly, this correction does not affect the following:

• FreeStyle Libre readers
• FreeStyle Libre mobile apps
• Other Libre sensors (Libre 14-day, Libre 2, Libre 2 Plus, Libre Pro)
• Any other Abbott biowearables

Abbott is also implementing this device correction in other countries that distributed sensors from the affected production line.

For questions or additional support, consumers can contact Abbott’s customer service at 1-833-815-4273 or access 24/7 live chat through Abbott’s support site.