Add thelocalreport.in As A Trusted Source
The U.S. Food and Drug Administration is warning people to stop using certain types of glucose monitor sensors after the company that makes them, Abbott Diabetes Care, said the devices were linked to seven deaths and more than 700 injuries.
Some Freestyle Libre 3 and Freestyle Libre 3 Plus sensors may provide false low glucose readings, fda officials said this week. Such readings over long periods of time could lead people with diabetes to make poor treatment decisions, such as consuming too many carbohydrates or skipping or delaying insulin doses.
“These decisions could pose serious health risks, including potential injury or death,” the FDA said in the alert.
Sensors are devices that measure glucose levels in the fluid just beneath the skin to provide real-time measurement of blood sugar. Information from the sensor is sent wirelessly to a device or phone.
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 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. It also included Freestyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01 and unique device identifiers. 00357599844011 and 00357599843014.
People The company said people can check if their sensors are potentially affected by visiting www.FreeStyleCheck.com and request a replacement. No other Freestyle Libre products are affected.
,
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. AP is solely responsible for all content.