BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1033172 · Received April 23, 2008

    Report

    Report Number
    1823260-2008-03472
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 5, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT SHE OBTAINED THE BLOOD GLUCOSE COMPARISONS WITH RESULTS 256MG/DL, 156MG/DL AND 351MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM. THE RESULTS WERE OBTAINED WITHIN A 10 MINUTE TIMEFRAME. NO ACTIONS TAKEN OR 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 549807

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR GLIPIZIDE 1000MG/DAY 2 YRS