BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1760928 · Received July 17, 2007

    Report

    Report Number
    1823260-2007-06203
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    July 2, 2007
    Report Date
    July 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE VALUES OF 167 MG/DL BACK TO BACK WITH A RESULT OF 88 MG/DL WHEN TESTING WAS PERFORMED LESS THAN 5 MINUTES APART ON THE ADVANTAGE SYSTEM. NO ACTIONS OR TREATMENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE - LFR LFR ROCHE DIAGNOSTICS 549521

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR METFORMIN 5 MOS - 1000MG TWICE DAILY| SIMVASTATIN - 80MG ONCE DAILY| GLYBURIDE - 5MG TWICE DAILY| LEVOTHYROXINE - 0.1MG ONCE DAILY