BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 612159 · Received June 7, 2005

    Report

    Report Number
    1823260-2005-01559
    Event Type
    Injury
    Date Received
    June 7, 2005
    Date of Event
    May 30, 2005
    Report Date
    May 31, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED DEVICE =514 MG/DL. CUSTOMER CALLED DOCTOR AND HE ADVISED THEM TO GO THE E.R. (ER). HOSP TESTED CUSTOMER'S STRIPS AND THE RESULT =420 MG/DL AND THEIR DEVICE =144 MG/DL. LAB=60 MG/DL. CUSTOMER WAS GIVEN ORANGE JUICE AND GRAHAM CRACKED. CUSTOMER'S MEDICATION WAS INCREASED. NO CONTROLS WERE USED. A REQUEST WAS MADE FOR RETURN PRODUCT AND REPLACEMENT PRODUCT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS NA 546932

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R