BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1061547 · Received June 17, 2008

    Report

    Report Number
    1823260-2008-04792
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE CUSTOMER OBTAINED A 70 MG/DL AND 165 MG/DL BLOOD GLUCOSE COMPARISON ON THE ACCU-CHEK ADVANTAGE SYSTEM. THE REPORTER STATES THE CUSTOMER ALSO OBTAINED AN ADDITIONAL COMPARISON WITH BLOOD GLUCOSE RESULTS 87 MG/DL AND 162 MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM. ON BOTH OCCASIONS, TEST RESULTS WERE OBTAINED WITHIN 10 MINUTES. NO ACTION WAS TAKEN BASED ON THE READINGS. 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 549833

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR GLYBURIDE: 20MG/DAY - 3 YEARS| METFORMIN: 2000MG/DAY - 3 YEARS| AVANDIA: 8 MG/DAY - 8 MONTHS