BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5065964 · Received September 9, 2015

    Report

    Report Number
    3004753838-2015-80944
    Event Type
    Death
    Date Received
    September 9, 2015
    Date of Event
    January 12, 2015
    Report Date
    August 11, 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. IT WAS STATED THAT PATIENT EXPIRED FROM DIABETIC KETOACIDOSIS AND CARDIAC FAILURE. IT SHOULD BE NOTED THAT DIABETES MELLITUS IS A KNOWN CAUSE OF DEATH. HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE CONFIRMED WITHOUT THE CERTIFICATE OF DEATH.

    Description of Event or Problem · 1

    PATIENT'S SISTER CONTACTED DEXCOM CUSTOMER SERVICE ON 08/11/2015 TO REPORT A PATIENT DEATH THAT OCCURRED ON (B)(6) 2015. PATIENT'S SISTER STATED THAT THE PATIENT WAS FOUND BY PATIENT'S MOTHER. THE PATIENT HAD ALREADY PASSED AWAY WHEN HE WAS FOUND BY HIS MOTHER. NO MEDICAL INTERVENTION WAS NECESSARY. PATIENT'S SISTER STATED THAT EMERGENCY MEDICAL TECHNICIAN (EMT) WERE CONTACTED DUE TO TOWN PROCEDURE. PATIENT'S SISTER STATED THAT PATIENT WAS WEARING HIS DEXCOM CONTINUOUS GLUCOSE MONITOR (CGM) AT THE TIME OF DEATH. ADDITIONALLY, PATIENT'S SISTER STATED THAT THE CAUSE OF DEATH WAS DIABETIC KETOACIDOSIS AND CARDIAC FAILURE. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597636 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649 5134463

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death