Robert Peirce & Associates, P.C. is actively investigating potential claims involving defective glucose monitor sensors manufactured by Abbott Diabetes Care, following a recent FDA Early Alert identifying potential safety risks associated with certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors.
The FDA issued its alert after Abbott confirmed that some sensors may provide incorrect low glucose readings, which could lead users to make inaccurate treatment decisions, including skipping insulin doses or consuming excess carbohydrates. These errors can cause serious health complications, such as diabetic ketoacidosis, heart events, neurological damage, or even death.
According to the FDA and Abbott, more than 700 serious adverse events and seven potential deaths have been reported worldwide in connection with this issue.
About the Abbott FreeStyle Libre Sensor Issue
On November 24, 2025, Abbott Diabetes Care issued a press release that it had initiated a “medical device correction” for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring (CGM) sensors distributed in the United States.
The company stated that it has identified and resolved the cause of the issue, which was traced to one of several manufacturing lines used to produce these sensors.
The affected products include:
- FreeStyle Libre 3 Sensor
- Model Numbers: 72081-01, 72080-01
- UDI-DI: 00357599818005, 00357599819002
- FreeStyle Libre 3 Plus Sensor
- Model Numbers: 78768-01, 78769-01
- UDI-DI: 00357599844011, 00357599843014
Abbott reports that approximately 3 million sensors from this production line were distributed in the U.S., with about half already used or expired.
Other FreeStyle Libre models (Libre 2, Libre 2 Plus, Libre 14-day, and Libre Pro) are not affected, nor are Libre readers, apps, or biowearables.
Why the FDA Issued an Early Alert
The FDA uses an Early Alert when it becomes aware of a potentially high-risk medical device issue that may pose immediate danger to patients before a formal recall process is completed.
In this case, Abbott confirmed that certain sensors could display falsely low glucose readings, leading to serious health risks if left undetected.
According to Abbott’s data:
- 736 severe adverse events have been reported worldwide (including 57 in the U.S.).
- Seven deaths have been linked to the sensor malfunction (none in the U.S. to date).
- The company has “identified and resolved” the production issue and is replacing impacted sensors at no cost to consumers.
The FDA continues to review this issue and has stated it will provide updates as more information becomes available.
What Users Should Do
Patients who use FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensors should immediately verify whether their sensors are affected.
According to Abbott, you should:
- Visit FreeStyleCheck.com and select “Confirm Sensor Serial Number.”
- Locate your sensor’s serial number (in your app, reader, sensor applicator, or carton) and enter it on the website to confirm if it’s affected.
- If your sensor is affected:
- Stop using it immediately and dispose of it safely.
- Request a replacement sensor through the FreeStyleCheck website (Abbott will provide replacements free of charge).
- Use a standard blood glucose meter or the built-in meter in your Libre 3 Reader if your sensor readings don’t match your symptoms.
Consumers may also contact Abbott Diabetes Care directly or through its support portal.
Healthcare providers and distributors have also been advised to contact affected patients, remove impacted products from circulation, and return affected sensors through the standard return process.
Potential Health Risks from Incorrect Glucose Readings
Continuous glucose monitors play a vital role in managing diabetes by helping users track glucose levels in real time and make dosing decisions. When a device provides incorrect readings, the consequences can be severe.
Prolonged reliance on faulty glucose data may lead to:
- Diabetic ketoacidosis (DKA)
- Severe hypoglycemia or hyperglycemia
- Heart complications, stroke, or organ damage
- Loss of consciousness or coma
- Death, in extreme cases
Users who experienced medical emergencies, hospitalizations, or worsened conditions while using affected FreeStyle Libre 3 sensors may have grounds to pursue a product liability claim.
Your Rights and Legal Options
Manufacturers of medical devices have a legal duty to ensure their products are safe, tested, and free from defects before they reach patients. When a defective device leads to serious harm, victims and their families may be entitled to compensation for:
- Medical expenses and hospitalization
- Lost wages and long-term care costs
- Pain, suffering, and emotional distress
- Wrongful death damages in fatal cases
Although Abbott has issued a “medical device correction” rather than a recall, the FDA’s Early Alert highlights the serious potential for patient injury, and legal accountability may arise as investigations continue.
How Robert Peirce & Associates, P.C. Can Help
Robert Peirce & Associates, P.C. has decades of experience representing clients in defective medical device and product liability claims nationwide. Our attorneys have successfully litigated cases involving dangerous consumer and medical products, helping victims recover the compensation they deserve.
If you or a loved one suffered harm related to a FreeStyle Libre 3 or Libre 3 Plus glucose monitor, or were hospitalized after relying on incorrect glucose readings, our team can help you understand your rights and options.
Call (844) 383-0565 or contact us online to speak confidentially with an attorney today. We offer FREE consultations and collect no legal fees unless we win.