The Food and Drug Administration is urging people to immediately stop using certain Abbott Faulty glucose sensors after the devices were tied to seven deaths and more than seven hundred injuries worldwide, according to an agency alert issued this week.
FDA Flags Faulty Sensors After Global Reports
The FDA said specific FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may deliver inaccurate low glucose readings, which can prompt dangerous treatment decisions such as skipping insulin doses or overeating carbohydrates.
“These decisions may pose serious health risks, including potential injury or death,” the agency said in the alert.
The devices measure Faulty glucose sensors in the fluid under the skin and send data wirelessly to a phone or reader for real-time monitoring. Abbott reported the problem in sensors produced on a single line, affecting about three million units in the United States. The company said roughly half of those sensors have been used or have expired.
As of Nov. 14, Abbott reported seven deaths and 736 serious adverse events worldwide. None of the deaths occurred in the U.S., though fifty-seven injuries were reported domestically.
Abbott Says Issue Identified and Resolved
Abbott has notified customers of the defect and said the underlying issue has been fixed in the affected production lot.
“We acted quickly to identify the cause and communicate with users,” the company said in a statement. “Our priority is ensuring the safety and reliability of our products.”
The FDA instructed users to stop using and discard the faulty sensors. The issue affects FreeStyle Libre 3 sensors with model number 72080-01 and unique device identifiers 00357599818005 and 00357599819002. It also affects FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01 and identifiers 00357599844011 and 00357599843014.
No other FreeStyle Libre products are included in the notice.
Officials Urge Replacement, Stress Ongoing Monitoring
Public health experts said the recall underscores the importance of vigilance when using continuous Faulty glucose sensors monitoring technology.
“Real-time data is vital for people with diabetes, but accuracy is equally crucial,” said Dr. Helen Morris, an endocrinologist at Johns Hopkins University. “Even small errors can lead to major medical consequences.”
FDA officials said people should confirm whether their sensors are affected by visiting FreeStyleCheck.com, where they can request replacements. The agency added that users should monitor symptoms and seek medical help if they suspect inaccurate readings.
Continuous Faulty glucose sensors monitors remain a critical tool for millions of people with diabetes worldwide. But, according to patient advocates, episodes like this highlight the need for robust manufacturing and oversight.
“People rely on these sensors to keep themselves safe,” said Karen Liu, director of a diabetes support group in California. “Timely communication and rapid corrective action are essential.”
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