BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1200122 · Received October 15, 2008

    Report

    Report Number
    1823260-2008-07612
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 350 MG/DL, 189 MG/DL, AND 122 MG/DL ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES. NO ACTION TAKEN ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER, STRIPS ARE UNAVAILABLE FOR RETURN.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR FEOSOL - 650MG/DAY| MULTIVITAMIN| COLACE - 100MG/DAY| ASPIRIN - 81MG/DAY| ZOCOR - 20MG/DAY| GLUCATROL - 2.5MG/DAY| ZANAFLEX - 4MG/DAY| LIDODERM| SINEMET| METFORMIN - 2000MG/DAY| NEXIUM - 40MG/DAY| VITAMIN B12 - 1000MG/DAY| VITAMIN C - 500MG/DAY| ARICEPT - 5MG/DAY| COREG - 25MG/DAY| FLOMAX - 0.8 MG/DAY| URECHOLINE - 75MG/DAY