BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1011687 · Received March 10, 2008

    Report

    Report Number
    1823260-2008-02273
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 10, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE CUSTOMER OBTAINED A 428MG/DL AND 172MG/DL BLOOD GLUCOSE COMPARISON ON THE ACCU-CHEK ADVANTAGE METER. THE RESULTS WERE OBTAINED WITH A 10 MINUTE TIMEFRAME. NO REPORTED ACTIONS TAKEN BASED ON THE BLOOD GLUCOSE RESULTS. 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 550079

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HUMULIN SLIDING SCALE| LANTUS 45 UNITS/DAY - 9 YEARS