**Title:** FDA Issues Warning on Faulty Glucose Monitor Sensors
**Meta Description:** The FDA alerts users to stop using certain glucose monitor sensors linked to serious health risks, including deaths and injuries.
**URL Slug:** fda-warning-glucose-monitor-sensors
**Headline:** FDA Alerts Users to Stop Using Faulty Glucose Monitor Sensors Linked to Serious Health Risks
The U.S. Food and Drug Administration (FDA) has issued a warning advising individuals to discontinue the use of specific glucose monitor sensors manufactured by Abbott Diabetes Care. This alert follows reports that these devices are associated with seven fatalities and over 700 injuries. The affected models, FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors, may deliver inaccurate low glucose readings, which can mislead individuals with diabetes into making harmful treatment choices, such as consuming excessive carbohydrates or delaying insulin doses. The FDA emphasized that such decisions could lead to severe health risks, including potential injury or death.
These sensors are designed to measure glucose levels in interstitial fluid just beneath the skin, providing real-time blood sugar readings. The data is transmitted wirelessly to a compatible device or smartphone. According to Abbott, approximately three million sensors from a single production line in the U.S. are impacted by this warning, with about half of these devices already expired or used. As of November 14, the company reported seven deaths globally and 736 serious adverse events, although no fatalities occurred in the U.S., where 57 injuries were documented.
Abbott has reached out to all customers regarding this issue and has confirmed that the problem within the affected production lot has been identified and resolved. The FDA advises users to stop using the implicated sensors and to dispose of them properly. The specific models involved include FreeStyle Libre 3 sensors with model numbers 72080-01 and unique device identifiers 00357599818005 and 00357599819002, as well as FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01, identified by unique device identifiers 00357599844011 and 00357599843014.
For those who may have affected sensors, Abbott encourages users to verify their devices and request replacements. Importantly, no other FreeStyle Libre products are implicated in this warning.
**FAQ Section:**
**Q: What should I do if I have an affected glucose monitor sensor?**
A: If you have a FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensor, stop using it immediately and dispose of it. Check with Abbott for replacement options.