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FDA: Dexcom recalls CGM systems due to alarm failure
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Dexcom Inc. issued a recall of its continuous glucose monitoring systems because the audible alarm may not activate in the receiver piece when low or high glucose levels 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.
Recalls include all model and lot numbers for the Dexcom G4 Platinum receiver, G4 Platinum pediatric receiver, G4 Platinum professional receiver, G4 Platinum receiver with share, G4 Platinum pediatric receiver with share and the G5 Mobile receiver.
The company sent an Important Customer Notification Letter on February 23 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.