Abbott’s FreeStyle Libre 3 and Libre 3 Plus Glucose Monitors Linked to 736 Injuries, 7 Deaths

FDA Raises Alarm Over Glucose Sensor Accuracy and Patient Safety

The U.S. Food and Drug Administration (FDA) has issued an urgent Early Alert following reports of serious injuries and deaths linked to specific continuous glucose monitor (CGM) sensors manufactured by Abbott Diabetes Care. These medical devices, intended to help people with diabetes monitor their blood sugar levels in real time, are now the subject of national concern. According to public warnings, the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may provide inaccurate low-glucose readings, which can lead to dangerous, and potentially fatal, treatment decisions.

As of early December 2025, 736 severe adverse events and seven potential deaths have been associated with the malfunctioning sensors. Both Abbott and the FDA are advising consumers to immediately stop using the affected models and dispose of them safely. While Abbott is offering free replacements, the damage for many families has already been done.

People who rely on glucose sensors for life-sustaining treatment decisions deserve to trust the information their devices provide. When a system designed to safeguard health instead causes serious harm or death, legal accountability becomes critical.

What Are Continuous Glucose Monitors and How Do They Work?

Continuous glucose monitors (CGMs) are a crucial tool for people managing diabetes. These small devices measure glucose levels in real-time throughout the day and night. A small sensor is inserted just under the skin, typically in the upper arm or abdomen. The sensor communicates with a reader, mobile app, or insulin pump to deliver updated glucose readings every few minutes.

Unlike traditional finger-stick tests, CGMs allow for immediate detection of rising or falling glucose levels. Patients can respond more quickly to avoid dangerous highs (hyperglycemia) or lows (hypoglycemia). Many CGMs also provide trend data and alerts, allowing users to adjust insulin, food intake, or physical activity in real time.

However, the system is only as reliable as the data it delivers. If a CGM provides false low glucose readings, a user might assume they are experiencing hypoglycemia when they are not — potentially leading to an increase in sugar intake or skipping needed insulin doses. Over time, these incorrect decisions can result in severe complications, including diabetic ketoacidosis, coma, organ damage, or death.

What the FDA And Abbott Have Disclosed About The Safety Issue

On November 24, 2025, Abbott issued a public announcement warning that some of its FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may be providing inaccurately low glucose readings. Users who rely on these readings for treatment decisions may end up making incorrect choices, such as consuming unnecessary carbohydrates or skipping insulin doses.

According to the manufacturer’s statement:

• 736 severe adverse events have been reported.
• 7 potential deaths may be linked to this device malfunction.
• The faulty readings are not obvious to users and may continue over an extended period.
• The issue is limited to the Libre 3 and Libre 3 Plus sensors.
• No other Abbott devices or mobile applications are affected.

On December 4, the FDA followed up with an Early Alert communication, indicating that this issue may warrant a recall. While the agency continues to gather additional data, it is urging immediate action for safety.

Potential Health Risks for Those Using Faulty Freestyle Libre Sensors

Faulty glucose sensors that report artificially low glucose levels can put users in a state of false hypoglycemia. Believing their blood sugar is dangerously low, they may take inappropriate steps:

• Consume high-sugar foods or drinks unnecessarily.
• Postpone or skip insulin doses.
• Misuse insulin pumps based on faulty readings.
• Avoid physical activity due to fear of dropping levels.

These decisions, when based on inaccurate data, can have catastrophic consequences. Over time, this can lead to:

• Chronic hyperglycemia which increases the risk of heart disease, nerve damage, kidney failure, and vision loss.
• Severe complications like diabetic ketoacidosis (DKA) occur when the body breaks down fat too rapidly, causing acid buildup in the blood.
• Death, especially in patients whose insulin levels are significantly off balance for extended periods.

In some of the 736 reported injury cases, individuals were hospitalized with serious complications. In 7 cases, the patient died — potentially as a result of false information from the very device they trusted to protect them.

Who Is Most at Risk from This Device Failure?

The patients most at risk from these CGM errors include:

• Children and adolescents who rely on automated insulin dosing systems.
• Older adults living alone or in assisted settings.
• Patients with Type 1 diabetes must maintain extremely tight glucose control.
• Individuals with cognitive impairments who cannot verify readings.
• Patients who use insulin pumps directly linked to CGM data for dosing decisions.

Because these users may trust the data implicitly, they are more likely to make treatment decisions without questioning the numbers. A faulty sensor can result in days or weeks of incorrect dosing, slowly building toward a life-threatening event.

What Users Are Being Told to Do Right Now

Both the FDA and Abbott are urging patients who use the FreeStyle Libre 3 and Libre 3 Plus sensors to take immediate action:

1. Stop using the affected sensors immediately.
2. Safely dispose of the faulty sensors.
3. Visit Abbott’s designated website to check whether your device is on the affected list.
4. Request a replacement device from Abbott at no cost.

The FDA also recommends that any user who experienced unusual symptoms or medical events while using the device should seek medical attention and report the incident to the agency through the MedWatch reporting system.

While replacement sensors are being made available, no amount of after-the-fact corrective action can undo the harm already caused to hundreds of patients and families. If a loved one suffered serious complications or died while using one of these devices, it is important to understand that legal options may be available.

Legal Options For Patients Harmed by Faulty Glucose Monitors

Patients and families impacted by these dangerous sensor errors may be eligible to file a product liability claim against Abbott. These claims may involve:

• Design defect: If the sensor’s design allowed for critical failure.
• Manufacturing defect: If only certain batches failed due to production problems.
• Failure to warn: If adequate risk warnings were not issued before the device reached consumers.
• Negligence: If the manufacturer failed to test or monitor the devices appropriately.

Depending on the circumstances, claims may also include:

• Medical expenses for emergency treatment or hospitalization.
• Lost wages and reduced earning capacity.
• Pain and suffering, emotional distress, and reduced quality of life.
• Funeral and burial costs in cases involving death.

Each case depends on the facts, including how long the device was in use, the nature of the harm, and whether a medical link can be established between the CGM failure and the injury. An attorney experienced in medical device litigation can investigate and help families determine whether they may be entitled to compensation.

Faulty Glucose Monitor Lawsuit FAQs

What products are affected by this safety alert?

The alert applies to Abbott’s FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitors. No other Abbott products or mobile apps are affected.

Why is the FDA warning consumers?

The FDA issued an Early Alert due to evidence that these sensors may deliver inaccurate low glucose readings. These errors can lead to serious treatment mistakes, hospitalizations, and in some cases, death.

How many people have been harmed so far?

Abbott has reported 736 severe adverse events and at least 7 possible deaths connected to the faulty glucose monitors.

What are the dangers of false low glucose readings?

Users may mistakenly eat extra sugar or skip insulin doses, leading to prolonged high glucose levels, which can result in complications like diabetic ketoacidosis, heart problems, and stroke.

Are there legal claims against Abbott for this issue?

Yes. Patients and families may be eligible to file product liability lawsuits seeking compensation for medical costs, lost wages, pain and suffering, or wrongful death.

Should patients who feel fine take any action?

Yes. If you have a sensor from the affected batch, stop using it immediately and contact Abbott for a replacement. Even if no symptoms are present now, prolonged exposure can still cause long-term harm.

What should I do if my loved one died while using this device?

Families who lost a loved one may pursue a wrongful death claim. A lawyer can help investigate whether the CGM device failure was a contributing cause.

Contact Parker Waichman LLP For A Free Case Review

If you or someone in your family suffered serious complications while using a FreeStyle Libre 3 or Libre 3 Plus glucose monitor, you may be entitled to compensation. These devices were supposed to protect health, not put lives at risk.

Call Parker Waichman LLP today at 1-800-YOUR-LAWYER (1-800-968-7529) for a free case review. Our national law firm is investigating injury and wrongful death claims involving these dangerous sensors. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you. There are no upfront fees, and we only get paid if we recover money for you.