The FDA has identified this as a Class I recall, the most serious type of recall. Relying on this device may cause serious injuries or death.
Dexcom Inc. is recalling the Continuous Glucose Monitoring Systems because the audible alarm may not activate in the receiver piece when low or high glucose levels (hypoglycemia or hyperglycemia) are detected.
Relying on this product for notification of low or high blood sugar could result in serious adverse consequences, including death as the auditory alarm may not sound and users might not be notified of low or high blood sugar.
hmm does this mean we have to send back all our receivers??? What are we supposed to do in the meantime? Mine seems to be ok- I have turned the sound off and just use vibrate, but it has alarmed a couple of times for a 50 bg when I was sleeping with the beep. I haven’t tested my spare yet, but I’m not sending them both back unless I’m getting an immediate replacement.
Reading the FDA’s page (posted by OP), it includes a set of instructions for testing the most critical alarm, Fixed Low. Failure of the receiver’s audible alarm when following the instructions at the FDA’s website constitutes failure, warranting return of the receiver.
Now, if they could only figure out the system’s other issues…
I had to return a G4, whether the low or high alarms sounded was hit or miss. I’m now only using my iPhone with the G5 transmitter so not sure if the replacement works, I can’t get the G5 software to load on it.
I’m sure most of 'em are fine. Easy to check (per the website):
What to Do
On February 23, 2016, Dexcom Inc. sent an Important Customer Notification Letter with the following instructions to test the audio alert on the receiver:
press the center button on your receiver to access the Main Menu
scroll down to Profiles
select Profiles
scroll down to Try It
select Try It
scroll down to 55 Fixed Low
select 55 Fixed Low
verify that you receive vibrations first (vibratory portion of alarm), followed by beeps (audible portion of alarm).
Customers should contact Dexcom at their free hotline number: (844) 607-8398, if the audio alert does not work properly.
I’ve wondered if this type of thing was going on with my G4 receiver. There’s been several times I’ve looked at it and the reading has been high or low but don’t recall hearing an alarm. And sometimes I’ll get an alarm a few minutes after I’ve calibrated it with a low or high reading at the time.
It should be noted that even if your receiver passes the test now, keeping an eye on & randomly testing the alarms is a good idea. They can stop working at any time.
This is what was happening to me @kevin8 I thought I just wasn’t hearing the alarms so I made an effort (while at home where it was quieter) to pay close attention and after a couple days determined that sometimes they sounded, sometimes not. To be honest I don’t think the test they advocate is 100% reliable, my advice, change your alert thresholds so they sound more often and then pay closer attention to your receiver to see if it works.
If you have a G5 your phone will alert you, I’m not using my replacement receiver at this point.
Just signed up for my replacement. For some reason it would never sound on the alarms only vibration. I ran the test and will hear audible sound but no sound when hitting low.
This confused us at first: the first time an alert triggers on the receiver it will only vibrate, it’s only after 5 minutes that it will make a sound as well as vibrating.
