NEWSBREAK: DEXCOM RECALL classified as most serious by FDA

Important NoticeIf you use the products discussed below, you should have received a letter from the Dexcom folks regarding the following.  This is copied exactly as written from the FDA page and the link to the actual page is at the bottom.  Please take heed to what is being said.  Devices are mechanical.  From time to time this will indeed happen, I have never known it to be different in over the last 23+ years I have been on this journey.  Companies do all they can to ‘right what went wrong’, follow the steps instructed to make sure your product is corrected.  SPECIAL NOTICE if your kids are not at home (away at school, vacation, moving around, etc) but the mail comes to your house.

Dexcom Inc. Recalls G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers Due to Audible Alarm Failure
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

Recalled Devices
  • Name of device: Dexcom G4 PLATINUM Receiver, Dexcom G4 PLATINUM (Pediatric) Receive, Dexcom G4 PLATINUM (Professional) Receiver, Dexcom G4 PLATINUM Receiver with Share, Dexcom G4 PLATINUM (Pediatric) Receiver with Share, Dexcom G5 Mobile Receiver
  • Model numbers: all models
  • Lot numbers: all lots
  • Manufacturing dates: July 29, 2011 to March 10, 2016
  • Distribution dates: October 22, 2012 to March 10, 2016
  • Devices recalled in the U.S.: 263,520 units nationwide
Device Use

The Dexcom Continuous Glucose Monitoring Systems are used to monitor the blood sugar (glucose) level of adult and pediatric patients with type 1 or type 2 diabetes. These glucose monitoring systems include a sensor that is placed under the skin to measure blood glucose readings that are sent to a hand-held receiver.  They are used in combination with standard home glucose monitoring devices in the management of diabetes.

Dexcom G4 Platinum Receiver

Dexcom G4 Platinum Receiver

Dexcom G5 Mobile Receiver

Dexcom G5 Mobile Receiver

Reason for Recall

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.

Who May be Affected
  • All patient groups using the Dexcom Continuous Glucose Monitoring Systems to monitor their blood glucose levels
  • Health care providers who prescribe these monitoring systems to patients in their care
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.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program  either online, by regular mail or by FAX.

Here is the link to the FDA page.
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm495448.htm

I am a diabetes dad.
Please visit my Diabetes Dad FB Page and hit ‘like’.

Leave a Reply

Your email address will not be published.

You may use these HTML tags and attributes:

<a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>