BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM

    MDR report key: 5065985 · Received September 9, 2015

    Report

    Report Number
    3004753838-2015-80965
    Event Type
    Death
    Date Received
    September 9, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 12, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000163
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAD NOT YET BEEN USED. THE DEATH CERTIFICATE WAS RECEIVED CONFIRMING THE ROOT CAUSE OF DEATH TO BE CARDIAC ARREST.

    Description of Event or Problem · 1

    PATIENT'S HUSBAND CONTACTED DEXCOM TECHNICAL SUPPORT ON 08/12/2015, TO REPORT THAT ON (B)(6) 2015, THE PATIENT EXPIRED. PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2015 DUE TO ARTERIAL FIBRILLATION AND DIFFICULTY BREATHING. PATIENT REMAINED IN THE HOSPITAL UP UNTIL HER PASSING. THE CAUSE OF DEATH WAS CARDIOGENIC SHOCK DUE TO VENTRICULAR FIBRILLATION AND VENTRICULAR TACHYCARDIA, LIVER CIRRHOSIS; END STAGE RENAL DISEASE. THE PATIENT WAS ON LIVER/KIDNEY TRANSPLANT LIST. THE PATIENT HAD NOT YET USED THEIR CONTINUOUS GLUCOSE MONITORING SYSTEM. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594535 DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22495-PNK 5202023 00386270000163

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| O