BEUDAMED
    FDA Adverse Event Death Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3831190 · Received May 23, 2014

    Report

    Report Number
    3004753838-2014-08142
    Event Type
    Death
    Date Received
    May 23, 2014
    Date of Event
    April 27, 2014
    Report Date
    April 28, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, A REPRESENTATIVE FROM THE (B)(6) CORONER'S OFFICE CONTACTED DEXCOM TECHNICAL SUPPORT REQUESTING INFORMATION ON HOW TO ACCESS DATA FROM THE RECEIVER DUE TO THE PATIENT EXPIRING ON (B)(6) 2014 WHILE WEARING THE DEXCOM CGM SYSTEM. THE CORONER'S OFFICE REPORTED EVENTS OCCURRING ON (B)(6) 2014. AT APPROXIMATELY 05:30 AM, THE PATIENT WAS LAST SEEN ALIVE BY HER HUSBAND AND WAS NOT FEELING WELL. AT APPROXIMATELY 08:30 AM, THE PATIENT'S HUSBAND FOUND HER UNRESPONSIVE, ACTIVATED 911 AND INITIATED CARDIOPULMONARY RESUSCITATION EFFORTS. THE PATIENT WAS PRONOUNCED DEAD AT 09:30AM AND HER BODY WAS TRANSPORTED TO THE CORONER'S OFFICE FOR EXAMINATION. THE CORONER'S OFFICE ALSO REPORTED THE PATIENT HAD BEEN STRUGGLING WITH HER BLOOD SUGAR AND NOT FEELING WELL FOR SEVERAL DAYS PRIOR TO HER DEATH. ON (B)(6) 2014 AT APPROXIMATELY 09:00AM, AN AUTOPSY WAS PERFORMED. THE OFFICIAL CAUSE OF DEATH HAS YET TO BE DETERMINED. ON (B)(4) 2014 DEXCOM'S IN HOUSE PHYSICIAN ((B)(4)) CONTACTED THE PATIENT'S PRIMARY CARE PHYSICIAN. THE PATIENT WAS REPORTED TO HAVE HAD A RECENT PROLONGED HOSPITALIZATION AND WAS CONTINUING USE OF NARCOTIC PAIN MEDICATION. THE PATIENT HAD A HISTORY OF RECURRENT AND SEVERE HYPOGLYCEMIA, CHRONIC PAIN AND CHRONIC CACHEXIA; ALL OF WHICH ARE BELIEVED TO HAVE CONTRIBUTED TO HER DEATH. DEXCOM ISSUED A RGA TO RETURN THE DEVICE FOR FURTHER INVESTIGATION AND WILL SUBMIT A FOLLOW UP REPORT IF MORE INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308401 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5135334

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death| O