BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1053175 · Received May 27, 2008

    Report

    Report Number
    1823260-2008-04319
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT SHE OBTAINED THE BLOOD GLUCOSE COMPARISON OF 389MG/DL AND 178MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM. THE RESULTS WERE OBTAINED WITHIN A 10 MINUTE TIMEFRAME. THE REPORTER FELT HYPERGLYCEMIC. NO REPORTED TREATMENT GIVEN. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550060

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR METFORMIN 2000MG/DAY - 6 YEARS