Abbott Diabetes Care has issued a warning concerning faulty glucose readings detected on certain models of its continuous glucose monitoring devices. This issue is potentially linked to seven reported fatalities and several hundred serious injuries.
Affected Devices and Scope
Approximately 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors are impacted. Internal testing determined that the problem originated from a single production line. Abbott estimates that around 1.5 million of these devices have either reached their expiration date or have already been used by consumers.
Risk Assessment and User Action
Abbott's internal testing indicated that "some sensors may provide incorrect low glucose readings." The company advises customers who confirm their device is affected to discontinue use immediately and dispose of it. Undetected incorrect low glucose readings over an extended period may lead to inappropriate treatment decisions for individuals managing diabetes, such as increased carbohydrate intake or the delay or omission of insulin doses. Such decisions carry serious health risks, including potential injury or death, in addition to other less severe complications.
Reported Incidents and Company Response
All seven reported fatalities occurred outside the United States. Of the 736 reported severe injuries, 57 occurred within the U.S. Abbott has stated that it continues the production of sensors through its manufacturing process and anticipates no significant supply disruptions due to this issue. Customers utilizing potentially affected sensors can visit FreeStyleCheck.com to ascertain the status of their device. Faulty sensors will be replaced by the company at no charge. The Food and Drug Administration (FDA) has released additional information regarding this recall.