BEUDAMED
    FDA Adverse Event Death Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4947938 · Received July 28, 2015

    Report

    Report Number
    3004753838-2015-50285
    Event Type
    Death
    Date Received
    July 28, 2015
    Date of Event
    June 28, 2015
    Report Date
    June 30, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGED DEVICE MALFUNCTION. THE REPORTED CAUSE OF DEATH WAS KIDNEY FAILURE. DIABETES MELLITUS IS A KNOWN CAUSE OF DEATH.

    Description of Event or Problem · 1

    PATIENT'S CARETAKER CONTACTED DEXCOM TECHNICAL SUPPORT ON 06/30/2015 TO REPORT PATIENT DEATH THAT OCCURRED ON (B)(6) 2015. PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2015 AND REMAINED THERE FOR A WEEK FOR KIDNEY FAILURE. AT THE TIME OF DEATH, PATIENT'S CONTINUOUS GLUCOSE MONITORING DEVICE WAS READING 300MG/DL DUE TO COLONOSCOPY RELATED ISSUES. CARETAKER STATED THAT THE CAUSE OF DEATH WAS KIDNEY FAILURE AND NOT DIABETES RELATED. THERE WAS NO ALLEGED DEVICE MALFUNCTION. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488387 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death ELIQUIS