7 deaths, more than 700 serious injuries linked with diabetes glucose monitor errors
About 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may be providing incorrectly low glucose readings, Abbott said. (Photo Credit: From Abbott via CNN Newsource)
(CNN) — Certain glucose monitors from Abbott Diabetes Care are providing users with incorrect glucose readings, an error that has been linked with the deaths of at least seven people and more than 700 serious injuries worldwide, according to an alert from the US Food and Drug Administration.
Incorrect glucose readings can lead to improper treatment. Abbott warned that about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors are affected, but no other Libre products. Patients can visit FreeStyleCheck.com to see if their sensors are affected and to get a replacement for free.
The FDA has also published specific information about the affected products in its alert. The agency considers this to be a “potentially high-risk issue” and will continue to update its website as information becomes available.
“Patients should verify if their sensors are impacted and immediately discontinue use and dispose of the affected sensor(s),” the FDA said.
“If undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses,” the agency said. “These decisions may pose serious health risks, including potential injury or death, or other less serious complications.”
About 60 of the injuries have happened in the US, Abbott said in a news release, none of them fatal.
Abbott said that the manufacturing issue affecting the products has been resolved and that it is continuing to produce the products. The company does “not expect significant supply disruptions” for people seeking to replace their monitor or for new orders.
About 1 in 10 people in the US — about 38 million people — have diabetes, according to the US Centers for Disease Control and Prevention. The disease is the seventh leading cause of death nationwide.
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