Abbot has issued a medical device correction for some of its glucose sensor products after identifying a manufacturing issue that can lead to falsely low glucose readings.
The correction affects about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors distributed in the U.S., roughly half of which have likely expired or been used, according to a Nov. 24 announcement from the company.
Abbott said it has received 736 reports of severe adverse events, including 57 in the U.S., possibly linked to the issue. Seven deaths, all of which occurred outside of the U.S., were also reported.
“If undetected, incorrect low glucose readings over an extended period may lead to incorrect treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses,” Abbott said in its notice. “These decisions may pose serious health risks, including potential injury or death, or other less serious complications.”
The company said it has resolved the problem, which stemmed from one of several production lines used to manufacture the affected sensors. The company does not expect significant supply disruptions and continues to produce the devices.
Anyone with a sensor that may be affected should immediately discontinue use and dispose of it, Abbott said, adding it would replace any affected device at no charge. The company provided a website users can check to determine whether their sensor may be affected.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.