The device corrections include the FreeStyle Libre 3 and FreeStyle Libre 3 Plus models in the United States. The FreeStyle Libre 3 system is a continuous glucose-monitoring (CGM) system that includes the sensor and a Libre app. The sensor is typically applied to the back of the patient’s upper arm and automatically streams glucose readings to a smartphone.
According to the company, incorrect low glucose readings over an extended length of time could lead to incorrect treatment decisions for those living with diabetes, including excessive carbohydrate intake or delaying insulin doses.
“These decisions may pose serious health risks, including potential injury or death, or other less serious complications,” the company report indicates.
Internal research was able to identify and resolve the problem, which was related to one production line where sensors may have expired or been used. Abbott noted it would continue to produce both sensors for replacement and new orders and does not foresee any significant supply disruptions.
Globally, the company has received reports of 736 severe adverse effects, including 57 in the United States, and seven deaths—none in the United States—associated with this issue.
Those consumers who may currently be wearing a sensor or have one that has been confirmed as potentially impacted should immediately stop using it and discard it, the company said.
“Consumers should use a blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader to make treatment decisions when sensor readings don’t match symptoms or expectations,” the report indicated.
The report notes that FreeStyle Libre 3 readers and mobile apps have not been impacted, nor have other Libre products or Abbott biowearables.
Headquartered in Abbott Park, Illinois, Abbott provides diagnostic products, medical devices, nutritionals, and branded generic medicines to consumers in more than 160 countries. It employs more than 114,000 people worldwide.
An autoimmune disease, Type 1 diabetes occurs when the immune system mistakenly destroys the pancreas beta cells that create insulin, a hormone that helps the blood glucose create energy. In most cases, Type 1 diabetes is diagnosed in young people.
In patients with Type 2 diabetes, the body is unable to use insulin properly, becoming insulin resistant. Over time, the pancreas becomes unable to produce enough insulin to maintain normal blood glucose levels. Type 2 is typically diagnosed in middle-aged and older adults.
Symptoms for both types can include extreme thirst, frequent urination, fatigue, blurry vision, numbness in the hands or feet, eye disease, and other life-threatening illnesses.
Gestational diabetes can be temporary, affecting up to 9 percent of pregnancies in the United States annually.
Left untreated, diabetes can lead to other complications such as cardiovascular disease, chronic kidney disease, hearing loss, eye disease, and other life-threatening issues.