Freestyle Libre 3 sensors monitoring blood glucose recalled in connection with 7 deaths
listen to this article
estimated 3 minutes
The audio version of this article is generated by text-to-speech, a technology based on artificial intelligence.
Some? Freestyle Libre 3 Plus Glucose Monitor Sensor May Provide False Low Glucose ReadingsHealth Canada said in an alert.
Abbott Diabetes Care recalled Some of its Freestyle Libre 3 and Freestyle Libre 3 Plus sensor kits, it says, were linked to seven deaths and more than 700 injuries.
“If undetected, prolonged false low glucose readings can lead to incorrect treatment decisions for people with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses,” Health Canada said In an alert posted on Wednesday.
The Canadian regulator said serious health risks, including possible injury or death or other less serious complications, could result from those decisions.
Health Canada said Users should find their sensor serial number and visit www.freestylecheck.com To determine whether they have potentially affected the product ,
,If confirmed, discontinue use immediately, dispose of affected sensor and request replacement.”
The US Food and Drug Administration also warned people to stop using the recalled glucose monitor sensors.
Sensors are devices that measure glucose levels in fluid just beneath the skin to provide real-time measurement of glucose or sugar in the blood. Information from the sensor is sent wirelessly to a device or phone.
30 lakh sensors affected in America
Abbott officials said in a statement that the alert affects approximately three million sensors from a single production line in the US.
The company said about half of those devices have expired or been used. As of November 14, the company reported seven deaths and 736 serious adverse events worldwide. There were no deaths in the US, where 57 injuries were reported.
Abbott says it has notified all customers about the problem. The company said it has identified and resolved the problem in the affected production area.
The FDA said people should stop using the affected sensors and discard them.
The problem involved Freestyle Libre 3 sensors with model number 72080-01 with unique device identifiers 00357599818005 and 00357599819002.
This also includes the Freestyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01 and unique device identifiers 00357599844011 and 00357599843014.
The company said people can visit www.FreeStyleCheck.com to check if their sensors are potentially affected and request a replacement. No other Freestyle Libre products are affected.
