Health Canada flags recall of FreeStyle Libre devices tied to deaths and injuries
Millions of wearable glucose sensors used by people with diabetes are under international recall after being linked to seven deaths and more than 700 injuries, triggering warnings from Health Canada and the US Food and Drug Administration (FDA), according to CBC News.
Health Canada said some FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may show incorrect low glucose readings.
Over time, this can drive “excessive carbohydrate intake or skipping or delaying insulin doses,” which can lead to “serious health risks, including potential injury or death, or other less serious complications,” according to an alert cited by CBC News.
Abbott Diabetes Care, which manufactures the devices, recalled certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensor kits after identifying a problem on a single production line that may cause inaccurate low readings.
The company said the affected products are potentially tied to seven deaths worldwide and 736 serious adverse events, as per The Canadian Press.
None of the reported deaths or adverse events occurred in Canada, Health Canada said Friday.
No deaths were reported in the US, where 57 injuries were logged, Abbott said in a statement referenced by CBC News.
About three million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US are affected, roughly half of which have already been used or expired, Abbott officials said.
The FDA issued an “early alert” advising people with affected sensors to “immediately stop using them and dispose of them,” according to The New York Times.
The sensors are placed just under the skin to measure glucose levels in the fluid beneath the surface and wirelessly send real-time readings of glucose, or sugar, in the blood to a device or phone, as explained by Health Canada and the FDA in alerts cited by CBC News.
The FreeStyle Libre readers and mobile apps are not affected, the FDA said, according to The New York Times.
Health Canada said users should locate their sensor serial number and visit www.freestylecheck.com to determine if their product is potentially impacted, as per CBC News.
The agency advised that, “If confirmed immediately discontinue use, dispose of the affected sensor and request a replacement,” a message echoed by the FDA, which also directed users to check serial numbers and obtain free replacements.
Abbott said it has “identified and resolved the production line issue” and does not expect any “significant” supply disruptions, according to statements reported by The Canadian Press.
CBC News reported that the company said it has notified all customers of the problem and that no other FreeStyle Libre products are affected.
