Medical device correction: FreeStyle Libre 3 (Abbott – December)
Abbott has announced a medical device correction for certain FreeStyle Libre 3 sensors. These sensors monitor blood glucose levels as part of the FreeStyle Libre system, which includes a sensor, reader, and app. The correction applies only to the sensor. No other Libre products or Abbott biowearables are affected.
The sensors are being corrected because some may give incorrect low glucose readings. Individuals with diabetes who get false low readings may make unsafe treatment decisions, such as such as excessive carbohydrate intake or skipping insulin doses. This can pose serious health risks, including injury or death.
The groups below are part of the correction.
- FreeStyle Libre 3 Sensor
- Model numbers: 72081-01, 72080-01
- Unique device identifiers (UDI-DIs): 00357599818005 and 00357599819002
- FreeStyle Libre 3 Plus Sensor
- Model numbers: 78768-01, 78769-01
- UDI-DIs: 00357599844011 and 00357599843014
If a patient’s device’s model number or UDI-DI is listed above, they should visit FreeStyleCheck.com and enter their sensor serial number to learn if their device is affected by the correction. The website explains how to find the serial number.
The FDA recommends that patients with affected sensors stop using them immediately and throw them away. They should then enter their contact information on the website so Abbott can send them a replacement sensor at no cost.
Abbott suggests that those with signs of low glucose or who think their glucose reading is wrong use any glucometer to do a fingerstick test. This includes the built-in blood glucose meter in the FreeStyle Libre 3 reader.
As of Nov. 14, Abbott had reported 736 serious injuries and 7 deaths associated with this issue. The FDA is reviewing this potentially high-risk device issue and will keep the public informed as new information becomes available.
To learn more about this recall, your patients can take one or more of the steps below.
- Talk to your or their pharmacist.
- Call Abbott at 1-833-815-4273. Help is available seven days a week from 8 a.m. to 8 p.m. ET.
- Visit the FDA website.