Faulty Glucose Monitor Sensors May Be Linked to Seven Fatalities, FDA Reports

Abbott Diabetes Care acknowledges over 700 injury reports

The U.S. Food and Drug Administration (FDA) has issued a warning that malfunctioning sensors in Abbott’s continuous glucose monitoring (CGM) system could be connected to seven deaths and more than 700 reported injuries. Abbott Diabetes Care confirmed that it has received the injury reports and is cooperating with regulators to investigate the issue.

What the FDA says

According to the agency’s latest safety communication, the problems appear to stem from sensor hardware failures that may cause inaccurate glucose readings. Inaccurate data can lead users to make inappropriate treatment decisions, potentially resulting in severe hypoglycemia or hyperglycemia.

Company response

Abbott Diabetes Care released a statement saying, “We take patient safety very seriously and are working closely with the FDA to identify the root cause of these sensor malfunctions. Our priority is to protect the health of people who rely on our CGM technology.” The company added that it is reviewing its manufacturing processes and has initiated a voluntary recall of the affected sensor batches.

Potential impact on patients

Patients currently using the implicated sensors are urged to:

• Check the sensor’s serial number against the FDA’s recall list.
• Monitor blood glucose levels with a backup finger‑stick meter.
• Contact their healthcare provider immediately if they experience any unusual symptoms.

Regulatory actions

The FDA is conducting a thorough investigation and may require Abbott to implement additional safety measures, such as enhanced quality‑control testing and updated user instructions. The agency also encourages healthcare professionals to report any adverse events related to CGM devices through the MedWatch system.

Looking ahead

While Abbott works to resolve the sensor issue, experts emphasize the importance of vigilance when using any medical device. “Patients should never rely solely on a single data point,” said Dr. Emily Rivera, an endocrinologist at the National Diabetes Center. “Regular cross‑checking with traditional glucose meters can help prevent dangerous misinterpretations.”