BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 500328 · Received December 5, 2003

    Report

    Report Number
    1823260-2003-00392
    Event Type
    Death
    Date Received
    December 5, 2003
    Date of Event
    June 12, 2003
    Report Date
    November 20, 2003
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER'S FAMILY MEMBER CALLED TO REPORT THAT THE PATIENT USED THE DEVICE TO CHECK THEIR BLOOD GLUCOSE AND OBTAINED A RESULT IN THE 200'S MG/DL. FAMILY MEMBER SAID PATIENT "CRASHED OUT" ABOUT FOUR HOURS LATER AND PASSED AWAY FROM LOW BLOOD GLUCOSE. FAMILY MEMBER DIDN'T FEEL THE DEVICE CONTRIBUTED TO THE INCIDENT. FAMILY MEMBER SAID THEIR GLUCOSE FLUCTUATED RAPIDLY OFTEN. CONTROLS WERE NOT USED ON THE SYSTEM. THE DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death