Photo illustration shows the Abbott Freestyle Libre 3 Plus glucose sensor applicator on a patient's arm on Thursday.
Jill Delso/Getty Images
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Jill Delso/Getty Images
Abbott Diabetes Care has warned of incorrect glucose readings on some of its devices, potentially leading to seven deaths and hundreds more serious injuries.
Some 3 million The company's FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors were affected by an issue that was determined to originate on the same production line through internal testing. Abbott estimates that about 1.5 million of those devices are expired or have already been used.
The company said in a press release that “internal testing has shown that some sensors may give incorrect low glucose readings.” Customers who confirm their device is affected “should immediately stop using and discard it,” Abbott said.
“If undetected, incorrect low glucose readings over an extended period can lead to poor treatment decisions for people living with diabetes, such as over-consuming carbohydrates 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 this process and the company does not expect significant supply disruptions due to the issue.
Of the seven deaths, all were outside the United States. Of the 736 “severe” injuries, 57 occurred in the United States.
Diabetes is a disease that affects the body's production of and response to the hormone insulin. Glucose monitoring helps people living with diabetes determine their blood sugar levels and make decisions about food and medications.
Abbott said customers using potentially affected sensors should visit FreeStyleCheck.com to determine the status of your device. The company said it will replace faulty sensors free of charge.
The Food and Drug Administration has additional information about the recall.
