BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 506956 · Received January 15, 2004

    Report

    Report Number
    1823260-2004-00005
    Event Type
    Death
    Date Received
    January 15, 2004
    Date of Event
    November 17, 2003
    Report Date
    January 3, 2004
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER'S WIFE REPORTED THAT PT USED THE DEVICE TO CHECK THEIR BLOOD GLUCOSE AND OBTAINED A RESULT OF 235 MG/DL AT 8:30AM. AT 9:00AM PT DIED ON IMPACT DURING A CAR ACCIDDENT. SPOUSE DID NOT KNOW IF PT TOOK ANY MEDS. SPOUSE STATED PT ATE A BOWL OF CHEERIOS AT 7:30AM. CONTROLS WERE NOT USED ON THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS NA 546636

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death