FDA Warns Millions to Stop Using Faulty Glucose Monitors Linked to Deaths and Injuries
The US Food and Drug Administration (FDA) has issued a warning to millions of glucose monitor users after discovering that certain devices made by Abbott Diabetes Care were producing inaccurate readings, resulting in seven reported deaths and over 700 injuries. The faulty sensors were found to provide incorrect low glucose readings, which can lead people with diabetes to make life-threatening decisions such as consuming excessive carbohydrates or delaying insulin doses.
The affected sensors were part of the FreeStyle Libre 3 and FreeStyle Libre 3 Plus devices, which measure glucose levels in fluid just beneath the skin. The devices send wireless data to a user's device or phone, but some sensors produced inaccurate readings, posing serious health risks.
The FDA has identified over three million sensors from one production line as potentially affected, with about half of them already expired or used up. Globally, seven deaths have been reported and 736 serious adverse events documented, although no fatalities occurred in the US where only 57 injuries were recorded.
Abbott Diabetes Care has notified all customers of the issue and has identified and resolved the problem in the affected production lot. The FDA advises users to stop using affected sensors and discard them immediately.
Users can visit Abbott's website to check if their sensors are potentially affected and request a replacement. However, it's essential to note that only certain FreeStyle Libre products are affected, and no other devices are impacted.
The recall has significant implications for millions of people worldwide who rely on these glucose monitors for their daily lives. The FDA's warning serves as a reminder of the importance of regular monitoring and maintenance of medical devices to ensure safety and efficacy.
The US Food and Drug Administration (FDA) has issued a warning to millions of glucose monitor users after discovering that certain devices made by Abbott Diabetes Care were producing inaccurate readings, resulting in seven reported deaths and over 700 injuries. The faulty sensors were found to provide incorrect low glucose readings, which can lead people with diabetes to make life-threatening decisions such as consuming excessive carbohydrates or delaying insulin doses.
The affected sensors were part of the FreeStyle Libre 3 and FreeStyle Libre 3 Plus devices, which measure glucose levels in fluid just beneath the skin. The devices send wireless data to a user's device or phone, but some sensors produced inaccurate readings, posing serious health risks.
The FDA has identified over three million sensors from one production line as potentially affected, with about half of them already expired or used up. Globally, seven deaths have been reported and 736 serious adverse events documented, although no fatalities occurred in the US where only 57 injuries were recorded.
Abbott Diabetes Care has notified all customers of the issue and has identified and resolved the problem in the affected production lot. The FDA advises users to stop using affected sensors and discard them immediately.
Users can visit Abbott's website to check if their sensors are potentially affected and request a replacement. However, it's essential to note that only certain FreeStyle Libre products are affected, and no other devices are impacted.
The recall has significant implications for millions of people worldwide who rely on these glucose monitors for their daily lives. The FDA's warning serves as a reminder of the importance of regular monitoring and maintenance of medical devices to ensure safety and efficacy.
like I know the FDA can't be expected to catch every mistake but come on Abbott Diabetes Care how could you rush a product out without even testing it properly?! 
I mean we've all heard horror stories about glucose monitors giving false readings and now there's proof that it can be deadly. 
we need more than just a website to check for recalls, we need better system in place to keep people safe.
now let's hope that everyone takes action and replaces their faulty sensors ASAP 
guess thats just part of being a diabetic tho 
just thinking about all those people with diabetes having to deal with faulty glucose monitors is really worrying, can't imagine how stressful that must be for them... i mean, you rely on these things to manage your health 24/7, so when they're not working right it's like living on the edge 
. can you even imagine not knowing whether your body is getting enough insulin because some sensor said so? 
.
just saw this news about faulty glucose monitors linked to deaths & injuries... like, how many people rely on these things?! 
According to the FDA, 3M+ sensors are affected worldwide (with 57 in the US & 736 globally), which is CRAZY 
. That's around 400,000+ users who might be at risk if they don't get their sensors checked ASAP! 
)
That's a lot of faulty sensors, right? 
. But still, this is WIDE AWAKE reminder of how important regular monitoring/maintenance of medical devices is 
Here's a rough estimate of the number of people affected by country:
they need to be able to trust their devices, you know? 
don't wait till it's too late 
just go to abbott's website and see if yours are affected 
. 
. Has anyone else heard about this? Are there any other glucose monitor brands that are considered safe now?
it's like, the thought alone gives me anxiety 
.
Can't believe it happened in the first place... poor ppl who got hurt or worse.