Certain glucose monitors from Abbott Diabetes Care are offering customers with incorrect glucose readings, an error that has been linked with the deaths of no less than seven individuals and greater than 700 critical accidents worldwide, in response to an alert from the US Food and Drug Administration.
Incorrect glucose readings can result in improper remedy. Abbott warned that about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors are affected, however no different Libre merchandise. Patients can go to FreeStyleCheck.com to see if their sensors are affected and to get a substitute without spending a dime.
The FDA has additionally printed specific information in regards to the affected merchandise in its alert. The company considers this to be a “potentially high-risk issue” and can proceed to replace its web site as data turns into accessible.
“Patients should verify if their sensors are impacted and immediately discontinue use and dispose of the affected sensor(s),” the FDA stated.
“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 company stated. “These decisions may pose serious health risks, including potential injury or death, or other less serious complications.”
About 60 of the accidents have occurred within the US, Abbott stated in a news release, none of them deadly.
Abbott stated that the manufacturing challenge affecting the merchandise has been resolved and that it’s persevering with to supply the merchandise. The firm does “not expect significant supply disruptions” for individuals looking for to interchange their monitor or for brand spanking new orders.
About 1 in 10 individuals within the US — about 38 million individuals — have diabetes, in response to the US Centers for Disease Control and Prevention. The illness is the seventh main reason behind demise nationwide.