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Medication Safety Alerts

Dexcom Glucose Systems Receivers Voluntary Recall

04/11/2016


On April 11, 2016, the United States Food and Drug Administration (FDA) issued a notice regarding a voluntary recall of continuous glucose monitoring systems manufactured by Dexcom. This recall was issued 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 side effects, including death because the auditory alarm may not sound and users might not be notified of low or high blood sugar.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

A complete list of affected products is provided here:

Plan members should test their receivers to see if the audio alert is working correctly. To test the audio alert on your 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).

Plan members should contact Dexcom if the audio alert does not work properly, toll-free at 1‑844-607-8398.

Please call your doctor right away for advice if you have additional concerns. Your doctor is familiar with your medical history and can suggest the best treatment option for you.

CVS/caremark Response: If you are currently using continuous glucose monitoring systems manufactured by Dexcom, please call a Customer Care representative toll-free at 1-866-823-5184 for more information.

If you are currently taking continuous glucose monitoring systems manufactured by Dexcom and have questions regarding this recall, please call your doctor or call Dexcom toll-free at 1-844-607-8398 or visit https://www.dexcom-notification.com/cgm. You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their web site at https://www.fda.gov/Safety.

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