The Food and Drug Administration said on Tuesday that people should stop using certain types of glucose monitor sensors after the maker, Abbott Diabetes Care, warned that the faulty products could be tied to at least seven deaths.
About 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may provide incorrect low glucose readings, which could lead people with diabetes to manage the disease incorrectly, according to Abbott Diabetes Care, a division of Abbott Laboratories, a health care company.
The F.D.A. alert applies specifically to sensors that are placed just under the skin and provide real-time measurements of glucose, or sugar, in the blood. Information from the sensor is then transferred wirelessly to a device or phone. The FreeStyle Libre readers and mobile apps are not affected by the issue, the F.D.A. said.
A person who gets an incorrect reading for an extended period, and does not realize, may treat the disease incorrectly, for example by consuming too many carbohydrates or delaying insulin doses. As a result, serious health risks, including injury or death, are possible, according to Abbott Diabetes Care.
There have been 736 reports of injuries, including 57 in the United States, potentially tied to these sensors, Abbott Diabetes Care said in a news release on Nov. 24. The seven deaths were all outside the United States, the company said. These numbers were current as of Thursday, according to Abbott Diabetes Care.
The F.D.A. on Tuesday issued an “early alert,” a warning it provides to the public about potentially high-risk medical device removals or corrections, for the sensors. People who have the affected sensors should immediately stop using them and dispose of them, the agency said.
Abbott Diabetes Care estimated that about half of the affected sensors have been used or expired. The company said owners of FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors could go to a website, freestylecheck.com, or call the company’s customer service number, 1-833-815-4273, to check the serial numbers to see if their sensors are affected and to get a free replacement. The F.D.A. also provided a list of the more than 750 affected lots of sensors.
The faulty sensors were made on one production line, according to Abbott Diabetes Care, adding that the cause of the problem, which the company did not specify, had been identified and resolved. The company said it would continue to make new sensors and did not expect any “significant” supply disruptions.
Amanda Holpuch covers breaking news and other topics.
The post Faulty Glucose Monitor Sensors May Be Tied to 7 Deaths, F.D.A. Says appeared first on New York Times.
