BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5101031 · Received September 24, 2015

    Report

    Report Number
    3004753838-2015-81246
    Event Type
    Death
    Date Received
    September 24, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 28, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGED DEVICE MALFUNCTION. IT WAS STATED THAT PATIENT EXPIRED FROM A RARE CASE OF MENINGITIS. 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

    SUBSEQUENT TO THE INITIAL MDR, THE PATIENT'S DEATH CERTIFICATE WAS RECEIVED ON 10/14/2015. THE CAUSE OF DEATH WAS CONFIRMED TO BE NATURAL VIRAL MENINGITIS. NO ADDITIONAL EVENT OF PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    TERRITORY BUSINESS MANAGER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015, TO REPORT A PATIENT DEATH THAT OCCURRED ON (B)(6) 2015. PATIENT'S WIFE REPORTED PATIENT PASSED AWAY AS A RESULT OF A RARE CASE OF MENINGITIS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631241 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. UNKNOWN NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death