The FDA reported that Dexcom has issued a voluntary recall for their G4 Platinum and G5 Mobile Continuous Glucose Monitoring Systems (CGM). The company has undertaken the recall because of reports that the G4 and G5 audible alarm systems are not sounding. The FDA is treating this recall as a Class I recall, meaning device failure could cause serious injury or death.
Recently, Dexcom wrote an apology to customers in response to the complaints received about the CGM alarm systems. Dexcom officials recommend all customers check the alarms on their devices by following the directions below:
- Press the center button on your receiver to access the Main Menu
- Scroll down to Profiles
- Select Profile
- 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).
You can find the full instructions here: https://www.dexcom-notification.com/cgm. Once the test is completed, Dexcom gives further instructions. If everything tests properly, the company says that a replacement receiver is not needed, but they ask for user information, presumably if a future problem is detected. If a problem is detected with the test, Dexcom gives instructions for obtaining a replacement receiver.
Underneath the instructions is an online form you can fill out about the results of the alarms test. Customers also can contact Dexcom through their their CGM recall hotline at (844) 607-8398 or by dialing (858) 291-1700. The FDA also asks that Dexcom users report any problems to the FDA at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.
This recall represents one of the most serious challenges to Dexcom to date. In recent years, the Dexcom CGM product line has been considered something of a gold standard, and the Dexcom CGM has been favored by many artificial pancreas researchers. It remains to be seen what long-term impact this recall will have on the company’s reputation.
4-19-2016 – This article has been edited to clarify instructions for what to do after testing the CGM.
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