They are confirming at least 7 deaths due to poor accuracy in low readings:
" 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."
That article required me to have a subscription to the NY Times in order to read it, so I found a site that has the info without requiring subscription.
@Michel 's second link, the “Abbott” one, is to the recall advisory from Abbott and is not paywalled. Here it is again, out-of-line, so that FUD will expand it:
In essence it would seem that some Libre 3 and/or Libre 3 Plus sensors from a manufacturing run of about 3 million in the US can produce false low BG readings resulting in failure to take insulin. In full:
If undetected, incorrect low glucose readings over an extended period may lead to incorrect treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses.
I’m guessing the 7 deaths were from DKA and that this was correlated with (false) low BG readings from the sensors.
I’m further guessing the sensors “stuck” low. The Dexcom sensors certainly read low, quite frequently, but they don’t seem to stick; they either fail or they correct.
All speculation. The main point is to check the sensor batch number on the Abbott web site:
Consumers should visit www.FreeStyleCheck.com to confirm whether their sensor is potentially affected by this medical device correction. Abbott will replace any potentially affected sensors at no charge. Detailed instructions on how to check sensors and request a replacement are available on www.FreeStyleCheck.com.
100% of my Libre 3 and Libre 3 Plus sensors went low…perhaps a few thousand times, causing constant low alarms that couldn’t be turned off. Hardly rare, isolated occurrences. Every sensor failed. It’s why I moved to the G7.
