Dexcom Recall of G4 Platinum and G5 Mobile CGM Receivers

On April 11, device manufacturer Dexcom recalled their G4 Platinum and G5 Mobile Continuous Glucose Monitoring (CGM) System Receivers due to the potential for audible alarm failure. The CGM systems are used for monitoring glucose levels in adults and children with Type 1 or Type 2 diabetes in combination with standard home blood sugar monitors.

The recalled devices are all models and all lots of the Dexcom G4 Platinum Receiver, Dexcom G4 Platinum (Pediatric) Receiver, Dexcom G4 Platinum (Professional) Receiver, Dexcom G4 Platinum Receiver with Share, Dexcom G4 Platinum (Pediatric) Receiver with Share, and Dexcom G5 Mobile Receiver. These receivers were manufactured from July 29, 2011 to March 10, 2016 and distributed from October 22, 2012 to March 10, 2016.

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According to the company’s press release, “You may not receive an intended audible alarm or alert if you rely on hearing the alarm or alert. As a result, you may not detect a severe hypoglycemic (low glucose) or hyperglycemic (high glucose) event.”

Customers are advised to periodically test the alarms and alerts on their receiver to ensure they are functioning properly, particularly if the receiver gets wet or is dropped. Per instructions from Dexcom, the audio alert can be tested via the following steps:

• 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)

If the audio alert does not work properly, customers should contact Dexcom on their toll-free hotline number, (844) 607-8398.

For more information on the Dexcom recall, see the recall notification on the FDA’s website or select your country on the Dexcom website to read the customer notification.

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