The U.S. Food and Drug Administration (FDA) has issued an urgent alert, instructing individuals to immediately cease using specific models of continuous glucose monitor sensors. This directive follows a report from the manufacturer, Abbott Diabetes Care, linking the devices to seven fatalities and more than 700 injuries worldwide.
Critical Malfunction Poses Severe Health Risks
Officials stated this week that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may be providing incorrect low glucose readings. For people living with diabetes, relying on such faulty data over an extended period can lead to dangerous treatment decisions. This includes consuming excessive carbohydrates or, more perilously, skipping or delaying vital insulin doses.
"These decisions may pose serious health risks, including potential injury or death," the FDA emphasised in its public safety communication. The sensors are designed to measure glucose levels in interstitial fluid just under the skin, sending real-time data wirelessly to a receiver or smartphone to aid in diabetes management.
Scale of the Problem and Company Response
Abbott has confirmed the warning affects approximately three million sensors in the United States originating from a single production line. The company noted that roughly half of these devices have already expired or been used. As of 14 November, Abbott's global data showed seven reported deaths and 736 serious adverse events. While no deaths occurred in the U.S., 57 injuries were reported there.
In a statement, Abbott said it has notified all customers about the defect and has identified and resolved the issue within the affected production lot. The FDA's instruction remains clear: people should stop using and discard the affected sensors.
How to Identify and Replace Affected Sensors
The specific models involved are:
- FreeStyle Libre 3 sensors with model number 72080-01 and unique device identifiers (UDIs) 00357599818005 and 00357599819002.
- FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01 and UDIs 00357599844011 and 00357599843014.
Abbott has set up a dedicated website, www.FreeStyleCheck.com, where users can verify if their sensor is from the affected lot and request a replacement. The company stresses that no other FreeStyle Libre products are involved in this alert.
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