FDA: Seven deaths and 736 serious injuries due to issue with some FreeStyle Libre glucose monitoring systems

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The FDA has issued an alert after Abbott Diabetes Care stated that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors provide incorrect low glucose readings. (Abbott)

The Food and Drug Administration (FDA) has issued an alert after certain FreeStyle Libre glucose monitor sensors are providing incorrect low glucose readings.

What we know:

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:

• FreeStyle Libre 3 SensorModel Numbers: 72081-01, 72080-01Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002
• Model Numbers: 72081-01, 72080-01
• Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002
• FreeStyle Libre 3 Plus SensorModel Numbers: 78768-01, 78769-01Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014
• Model Numbers: 78768-01, 78769-01
• Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014

According to the FDA, FreeStyle Libre 3 readers and mobile apps are not impacted and no other Libre products (FreeStyle Libre 14 day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, or Libre Pro sensors) or Abbott biowearables are impacted.

What you can do:

The serial number can also be found on the label on the bottom of the sensor applicator or carton. (Abbott)

The FDA says patients can determine if their current or unused sensor(s) 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(s).

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