BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1053189 · Received May 27, 2008

    Report

    Report Number
    1823260-2008-04327
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 22, 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
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 385 MG/DL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 141 MG/DL ON THE PROFESSIONAL SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. NO ACTIONS WERE REPORTEDLY TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. REPORTER STATED THAT HE RAN CONTROLS ONE WEEK AGO AND THEY WERE IN RANGE. 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 550042

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR METFORMIN - 4 YEARS - 500MG TWICE DAILY