BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1336832 · Received March 10, 2009

    Report

    Report Number
    1823260-2007-05158
    Event Type
    Malfunction
    Date Received
    March 10, 2009
    Date of Event
    May 9, 2007
    Report Date
    June 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    KO10362
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES:LISINOPRIL 10MG/ 1X A DAY - 5 YRSAVANDIA 4MG/ 2X A DAY - 5 YRSMETFORMIN 500MG/ 2X A DAY - 5 YRSPOTASSIUM 20MG/ 1X A DAY - 5 YRSFERROUS SULFATE 325MG/ 1X A D - 5 YRSASPIRIN 81MG/ 1X A DAY - 5 YRSFUROSEMIDIE 40MG/ 1X A DAY - 5 YRSSINGULAIR 5MG/ 1X A DAY - 5 YRSFLOVENT 110MG/ 2 PUFFS A DAY - 4 YRSALBUTEROL 8.5MG/AS NEEDED - 5 YRSSPIRIVA 1X A DAY - 5 YRS

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING ON THE SAME METER USING THE ADVANTAGE SYSTEM WITH RESULTS OF 107 MG/DL AND 223 MG/DL. NO CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 549614

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR 70/30 NOVALOG 7 YRS| LIPITOR 20MG/ 1X A DAY 5 YRS| GEMFIBROZIL 600MG/2X A DAY 5 YRS