The Food and Drug Administration (FDA) has issued an urgent alert advising users to immediately stop using certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose sensors. The warning came after the device’s manufacturer, Abbott Diabetes Care, reported that the devices may provide incorrect glucose readings. According to Abbott, incorrect readings have been potentially linked to:
- At least 736 injuries worldwide, including 57 in the United States
- Seven deaths, all reported outside the United States
Close to 3 million Libre 3 and Libre 3 Plus sensors in the U.S. are thought to be affected. Abbott reported that all problematic sensors came from one manufacturing line. The company says it identified and fixed the issue and does not expect significant supply shortages. Note that this alert does not involve the FreeStyle Libre apps or readers, only the sensors themselves.
The Issue
These devices, often called continuous glucose monitors or CGMS, are normally worn on the back of the arm and use a small needle to continuously monitor glucose levels, sending real-time data to a reader or smartphone. While continuous glucose monitors can be lifesaving, they can also be deadly if they malfunction.
When faulty sensors report glucose reading that are too low, the wearer doesn’t know what their actual values are and may make treatment decisions that result in poorly controlled blood sugar. Extremely high or low blood glucose levels (or a wide variations in levels) can cause health issues. Some may experience symptoms like low energy, headaches, blurred vision, and fainting. However, serious issues such as heart and kidney disease, strokes, infections, diabetic ketoacidosis, or even death may also result. Any time blood glucose levels are abnormal, it is a serious medical concern.
What To Do
The FDA recommends that anyone using one of the affected sensors:
- Stop using the sensor immediately. Remove it and dispose of it safely.
- Check whether your sensor is part of the recall. You can verify your serial number at freestylecheck.com, or call Abbott’s customer line at 1-833-815-4273.
- Request a free replacement. Abbott is offering replacements at no cost.
If you have a faulty sensor and have medical complications associated with the abnormal readings, contact our office. At Schlesinger Law Offices, we have a long history of holding negligent medical device manufacturers accountable. Our firm has recovered millions of dollars for clients harmed by dangerous or defective products.
What This Means for Consumers
This incident highlights how defective products can create real danger for users. While Abbott is warning users and offering replacements, millions of devices are currently already in use and many patients may not realize their readings have been inaccurate. If you or someone you care about uses a FreeStyle Libre 3 sensor, checking the device now is the safest next step.
If You’ve Been Harmed, We Can Help
Faulty medical devices can lead to serious health complications including unnecessary hospital visits, improper dosing decisions, and long-term injury. When a company releases a product that fails to perform as promised, the law allows injured individuals to pursue compensation for the harm they’ve suffered.
Schlesinger Law Offices has a long history of holding major corporations accountable when their products put people at risk. If you believe you experienced harm connected to a defective glucose sensor, our team can evaluate your situation, help determine whether the device involved is part of the FDA alert, and explain your legal options. You don’t have to navigate this alone.