BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 909805 · Received September 7, 2007

    Report

    Report Number
    1823260-2007-07842
    Event Type
    Malfunction
    Date Received
    September 7, 2007
    Date of Event
    July 20, 2007
    Report Date
    September 7, 2007
    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

    REPORTER ALLEGED DISCREPANT BACK TO BACK BLOOD GLUCOSE VALUES OF 164, 142, 114, 259, AND 136 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. 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 TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549801

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR NOVOLONG - 30-40UNITS THREE TIMES DAILY| BACTRIM - 2PILLS ONCE DAILY FOR 1 MONTH| BETAPAC - 120MG TWICE DAILY| ZESTRIL - 40MG TWICE DAILY| HYDRALAZINE - 50MG TWICE DAILY| BUMEX - ONCE DAILY| COUMADIN - 5 MG - 1& 1/2 ONCE DAILY 3 DAYS WEEKLY| COUMADIN - 5MG 4 DAYS A WEEK| ALDACTONE - ONCE DAILY| NORVASC - 10MG TWICE DAILY| LANTUS - 60UNITS ONCE DAILY| LANOXIN - 20YRS 0.125MCG ONCE DAILY