Seven deaths possibly linked to malfunctioning glucose monitors
Malfunctioning glucose trackers made by Abbott Diabetes Care have been linked to more than 700 severe adverse events and seven potential deaths, the Food and Drug Administration (FDA) and Abbott said.
The medical device manufacturer first issued a public statement and sent a letter notifying those possibly impacted on Nov. 24, saying it had initiated a "medical device correction" for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors. The FDA issued an early alert on Dec. 2, a type of notice sent out when a company removes or corrects a product for high safety risks before the FDA can determine if a formal recall is required.
Some FreeStyle Libre 3 sensors may provide incorrect low glucose readings, prompting incorrect treatment decisions for people with diabetes. When a diabetic's blood sugar (AKA glucose) is low, they may do things to make it higher or prevent it from getting lower, like skipping or delaying an insulin dose (which is used to lower blood sugar) or eating too many carbohydrates, which raises glucose in the body.
These treatment decisions based on incorrect readings could cause blood sugar to be improperly controlled, resulting in serious complications and health risks, including injury or death. Some common complications of mismanaged blood sugar in diabetics include diabetic ketoacidosis, heart disease or attack, stroke, kidney, nerve or eye damage, and increased risk of infection.
