Sufferers are being warned to cease utilizing some glucose displays made by Abbott Diabetes Care after the corporate discovered malfunctioning sensors could also be linked to a whole bunch of hostile occasions and several other deaths, the Meals and Drug Administration stated Tuesday.
Inner testing by Abbott discovered that some sensors in sure FreeStyle Libre 3 and FreeStyle Libre 3 Plus units might present incorrect low glucose readings, the corporate stated in a information launch. Abbott stated it had obtained stories of 736 hostile occasions doubtlessly linked to the problem. Fifty-seven had been reported in the USA. Seven deaths, none of which had been in U.S., had been doubtlessly related to the sensor error, Abbott stated. The FDA referred to the error as a “doubtlessly high-risk difficulty” in a information launch.
Folks with diabetes rely upon glucose readings to handle their care. Incorrect low readings can result in extreme carbohydrate consumption or skipped or delayed insulin doses, Abbott stated. These selections “might pose severe well being dangers, together with potential harm or demise,” the corporate stated.
The sensor difficulty was associated to at least one manufacturing line among the many a number of that make the Libre 3 and Libre 3 Plus sensors, Abbott stated. About three million units are affected, about half of that are estimated to have expired or been used.
Anybody utilizing a Libre 3 or Libre 3 Plus sensor ought to test its mannequin quantity and distinctive machine identifiers to see if it is likely one of the affected units, the FDA and Abbott stated.
The mannequin numbers for the affected FreeStyle Libre 3 sensors are 72081-01 and 72080-01, and the distinctive machine identifiers are 00357599818005 and 00357599819002. The mannequin numbers for the affected FreeStyle Libre 3 sensors are 78768-01 and 78769-01, and the distinctive machine identifiers are 00357599844011 and 00357599843014. The complete checklist of affected tons is on the market on the FDA’s web site.
Anybody with an impacted machine ought to cease utilizing it, Abbott and the FDA stated. Sufferers can request free alternative units on www.FreeStyleCheck.com, Abbott stated. Sufferers ought to use a blood glucose meter or the built-in meter on a FreeStyle Libre 3 Reader to make remedy selections when sensor readings do not match signs or expectations, Abbott stated.
Abbott and the FDA stated that FreeStyle Libre 3 readers and cellular apps haven’t been impacted, and that no different Libre-brand sensors are affected by the sensor difficulty. The reason for the sensor difficulty has been recognized and resolved, Abbott stated, and no provide disruptions are anticipated.
