Abbott Diabetes Care has warned of faulty glucose readings on some of its devices, potentially linked to seven deaths and hundreds more serious injuries.
Some 3 million of the company's FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors were affected by the issue that was determined by internal testing to have resulted on a single production line. About 1.5 million of those devices are estimated to have expired or been used, Abbott said.
In a press release, the company said "internal testing determined that some sensors may provide incorrect low glucose readings." Customers who confirm their device is affected "should immediately discontinue use and dispose of it," Abbott said.
"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," the company said. "These decisions may pose serious health risks, including potential injury or death, or other less serious complications."
Abbott said it continues to produce sensors through the process and the company did not expect significant supply disruptions as a result of the issue.
Of the seven people who died, all were located outside of the United States. And of 736 "severe" injuries, 57 occurred within the U.S.
Diabetes is a disease that affects your body's production of and response to the hormone insulin. Glucose monitoring helps people living with diabetes to determine their blood sugar and make decisions on food intake and medication.
Abbott said customers using the potentially affected sensors should visit FreeStyleCheck.com to determine the status of their device. The company said it will replace faulty sensors at no charge.
The Food and Drug Administration has more information on the recall.
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