FDA warns of 7 deaths and more than 700 injuries linked to faulty glucose monitors

The U.S. Food and Drug Administration (FDA) has issued a warning advising people to stop using certain glucose monitor sensors after Abbott Diabetes Care reported that their devices were connected to seven deaths and over 700 injuries worldwide.

FDA officials highlighted that some FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors might give inaccurate low glucose readings. Prolonged reliance on such faulty data could cause individuals with diabetes to make harmful decisions, such as overeating carbohydrates or skipping or delaying insulin doses. The FDA noted that these actions may result in serious health complications or even death.

These sensors measure glucose in the interstitial fluid beneath the skin and transmit the information wirelessly to a phone or other device, offering real-time blood sugar monitoring.

Approximately three million sensors from a specific production batch in the U.S. are affected, according to Abbott. About half of these devices are already expired or have been used. As of November 14, the company reported seven global deaths and 736 severe adverse events. In the U.S., no deaths occurred, but 57 injuries were documented. Abbott has informed all customers about the issue and stated that the problem in the affected batch has been identified and corrected.

The affected models include FreeStyle Libre 3 sensors with model number 72080-01 and unique device identifiers 00357599818005 and 00357599819002, as well as FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01 and unique device identifiers 00357599844011 and 00357599843014. Individuals can visit www.FreeStyleCheck.com to see if their sensors are impacted and request replacements.

The FDA advises users to immediately stop using the affected sensors and properly dispose of them. Other FreeStyle Libre products are not affected by this alert.

Analysis: FDA Warning on Abbott Glucose Sensors

The recent FDA warning regarding certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors underscores the risks of relying on inaccurate glucose readings. Abbott Diabetes Care reported seven deaths and over 700 injuries worldwide linked to these devices, prompting immediate action.

The sensors in question may display falsely low glucose levels, potentially leading individuals with diabetes to make dangerous choices such as skipping insulin or overeating. While no deaths occurred in the U.S., 57 injuries were documented, highlighting the severity of the issue even domestically.

Approximately three million units from a specific batch are affected. Abbott has corrected the production issue and informed customers, with users able to check affected devices and request replacements via FreeStyleCheck.com.

Users should discontinue use of the identified sensors and properly dispose of them. Other FreeStyle Libre products remain unaffected, but vigilance is essential for anyone relying on continuous glucose monitoring.

Sources:

• Faulty glucose monitors linked to 7 deaths and more than 700 injuries, FDA warns