What Patients and Families Should Know About the FDA Alert, Reported Injuries, and Potential Legal Claims

The U.S. Food and Drug Administration (FDA) issued a public alert about a potentially high-risk problem involving certain Abbott Diabetes Care glucose monitoring sensors. According to the FDA, the agency became aware that specific sensors were producing incorrect low glucose readings. When a glucose monitor reports a reading that is falsely low, it can cause people living with diabetes to make treatment decisions based on information that is not accurate.

For many patients, glucose readings are not just numbers on a screen. They directly guide daily decisions such as whether to take insulin, how much insulin to administer, whether to eat carbohydrates, and whether emergency care is needed. A sensor that repeatedly shows low readings when glucose levels are not actually low can create a dangerous situation where the patient treats a problem that does not exist, while failing to treat the real condition that is happening inside the body.

The FDA’s alert highlights why device accuracy matters. A person may trust the device and delay insulin, reduce insulin, or skip insulin entirely. That decision can raise blood sugar to unsafe levels. In severe situations, high blood sugar can progress into life-threatening complications. The FDA’s involvement signals that the problem is not minor, especially when the agency connects the issue to serious injuries and reported deaths.

Which Abbott Devices Are Involved in the FDA Warning?

The FDA alert focuses on two glucose monitor sensors made by Abbott Diabetes Care:

• FreeStyle Libre 3 Sensor
• FreeStyle Libre 3 Plus Sensor

These sensors are used by people living with diabetes to track glucose levels, often continuously throughout the day and night. They are designed to help patients and caregivers manage diabetes in real time and respond quickly to changing blood sugar levels.

Abbott reported that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors had a manufacturing issue. The company also confirmed that more than 3 million sensors were affected, which raises serious questions about how widely this problem may have impacted consumers across the country.

The devices are used for diabetes management in people aged four and older, which means this issue may involve adults, teenagers, and young children. When medical devices are used by children, the risk profile can become even more concerning because young patients may not recognize symptoms quickly, may rely on parents or caregivers for treatment decisions, and may have less ability to advocate for themselves when something feels wrong.

Reported Injuries and Deaths: What the FDA Says Happened

One of the most alarming parts of the FDA’s alert is the reported harm connected to these incorrect readings. According to the FDA, Abbott reported:

• 736 serious injuries
• 7 deaths associated with the issue as of November 14.

When a medical device issue is linked to serious injury and death reports, it raises immediate concerns about patient safety, quality control, warnings, and how quickly the manufacturer acted once the issue was identified.

It is important to understand what “incorrect low glucose readings” can lead to in real life. A false low reading can cause a patient to take action that is medically unnecessary or harmful. This can include eating excessive carbohydrates, taking glucose tablets, drinking sugary liquids, or avoiding insulin. If this happens repeatedly, blood sugar can stay high for extended periods. That can increase the risk of complications, hospitalizations, and in severe cases, fatal outcomes.

When families lose a loved one in a situation involving a medical device failure, they are often left with painful questions. Was the device defective? Did the company know? Were consumers warned in time? Were replacements offered quickly enough? Those questions are often at the center of product liability investigations and lawsuits.

How False Low Glucose Readings Can Lead to Dangerous Treatment Decisions

Glucose sensors are intended to provide guidance that supports safe diabetes management. When a sensor falsely reports low readings, the user may respond as if hypoglycemia is happening. Hypoglycemia can be a medical emergency, so patients are trained to treat it quickly. That urgency is part of what makes false readings so dangerous.

According to Abbott’s own statements, incorrect low glucose readings over an extended period may cause decisions such as:

• Excessive carbohydrate intake
• Skipping insulin doses
• Delaying insulin doses

Each of these decisions can lead to serious health risks. When insulin is skipped or delayed, blood sugar can rise, sometimes rapidly. A patient may feel confused because the sensor suggests they are low, while their body feels symptoms that do not match. Some users may ignore their symptoms and trust the device. Others may repeatedly “correct” for lows that do not exist, leading to prolonged hyperglycemia.

This issue can be especially dangerous overnight. Many people rely on continuous glucose monitoring to detect problems while sleeping. If a device is showing false lows, a patient may take corrective action and then go back to sleep, unaware that their actual glucose levels are becoming dangerously high.

A defective reading can also affect medical decisions made by caregivers, school staff, and healthcare providers who are relying on the device data. When the information is wrong, the care decisions can be wrong, and the consequences can be severe.

Abbott’s Reported Manufacturing Issue and Replacement Instructions

Abbott informed customers that certain sensors were affected by a manufacturing issue. The company stated that it identified and resolved the cause of the issue impacting the sensors. Abbott also said that production continued so that replacements and new orders could be fulfilled.

Abbott advised users that when sensor readings do not match symptoms or expectations, they should confirm readings using:

• A blood glucose meter, or
• The built-in meter in the FreeStyle Libre 3 reader

This type of instruction matters because it acknowledges that sensor readings may not always be reliable and that patients should confirm with another method when something seems wrong.

Abbott also indicated that customers could check whether their sensors were affected and request a replacement. The company stated customers would not be charged for replacements.

However, when an injury or death occurs, replacement programs do not automatically resolve the harm that already happened. Families may still face medical bills, funeral expenses, lost income, and long-term emotional trauma. In those situations, many families explore whether they have legal options to pursue compensation.

Model Numbers and Device Identifiers Reported as Impacted

Abbott advised that the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors with specific model numbers and unique device identifiers were impacted.

FreeStyle Libre 3 Sensor

• Model Numbers: 72081-01, 72080-01
• Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002

FreeStyle Libre 3 Plus Sensor

• Model Numbers: 78768-01, 78769-01
• Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014

Patients can typically locate serial numbers through the app or reader, and also on the device label or carton.

If someone was harmed after using one of these sensors, it may be important to preserve the packaging, take screenshots of app readings, document symptoms, and keep records of emergency visits, lab results, and follow-up care. Those materials can become valuable evidence when investigating whether a device malfunction contributed to an injury.

What Injured Patients and Families Can Do After a Suspected Sensor Malfunction

When a medical device may have produced incorrect readings, the steps taken afterward can affect both health outcomes and legal rights. People dealing with a possible device malfunction should prioritize safety first, including getting medical care if symptoms are severe or do not match device readings.

In many cases, patients and families also want answers. They may want to know:

• Whether the device was part of a recall or safety alert
• Whether other consumers experienced the same problem
• Whether the device malfunction caused a medical emergency
• Whether the manufacturer issued warnings early enough
• Whether compensation may be available for injuries or wrongful death

The FDA encourages reporting adverse events through its MedWatch program. Reports like these help regulators track safety patterns and can support broader investigations into device failures.

For families who have experienced a severe outcome, including hospitalization, permanent injury, or loss of life, it may be appropriate to speak with a product liability attorney. These cases can involve complex medical evidence, device records, and corporate documentation that require thorough investigation.

FreeStyle Libre 3 Sensor Lawsuit FAQs

What kind of lawsuit could be filed over incorrect glucose readings from a medical device?

A case involving incorrect glucose readings may involve a product liability lawsuit, which can include claims such as defective manufacturing, defective design, or failure to provide adequate warnings. If a sensor malfunction caused serious injury, hospitalization, or death, the legal claim may focus on whether the device was unreasonably dangerous when used as intended and whether the defect contributed to the outcome.

Who may qualify to file a FreeStyle Libre sensor lawsuit?

Potential claimants may include people who used the affected sensors and suffered harm, as well as family members who lost a loved one. Eligibility often depends on the facts of the case, including the device model and identifiers, the medical outcome, and whether the injury can be connected to the incorrect readings.

What damages may be available in a glucose monitor injury case?

Depending on the facts, compensation may include medical expenses, future care costs, lost wages, reduced earning capacity, pain and suffering, and out-of-pocket costs. In wrongful death cases, damages may include funeral expenses, loss of financial support, and loss of companionship, subject to the laws of the state where the claim is filed.

Do I need proof that the device was recalled to have a claim?

Not necessarily. A recall or FDA alert can support a claim, but some lawsuits involve defective products even without a formal recall. Evidence may include medical records, device identifiers, app logs, lab glucose readings, witness statements, and documentation of the malfunction.

What should I save if I believe a sensor malfunction caused harm?

If possible, keep the sensor packaging, the carton label, model numbers, serial numbers, screenshots of readings, and any error messages. Also, keep medical records, discharge paperwork, EMS reports, and receipts. Preserving evidence early can be important if a claim is pursued.

Contact Parker Waichman LLP For a Free Case Review

If you or someone you love suffered serious harm after relying on a glucose monitor that provided incorrect readings, you may have the right to pursue compensation. Defective medical device cases can involve complex evidence, including device identifiers, medical records, and recall information. Parker Waichman LLP represents injured individuals and families nationwide and can evaluate whether you may have a claim connected to a malfunctioning glucose sensor.

Call Parker Waichman LLP today for a free consultation at 1-800-YOUR-LAWYER (1-800-968-7529). Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.