BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM

    MDR report key: 5105531 · Received September 25, 2015

    Report

    Report Number
    3004753838-2015-81349
    Event Type
    Death
    Date Received
    September 25, 2015
    Date of Event
    August 22, 2015
    Report Date
    September 2, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGED DEVICE MALFUNCTION. IT WAS STATED THAT PATIENT EXPIRED ON (B)(6) 2015. 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 CARE SPECIALIST CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015, TO REPORT A PATIENT DEATH THAT OCCURRED ON (B)(6) 2015. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635500 DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22495-PNK 5202160

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death