BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1040966 · Received May 8, 2008

    Report

    Report Number
    1823260-2008-03836
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS OF 66 MG/DL, 145 MG/DL, 127 MG/DL, 121 MG/DL, 129 MG/DL, 120MG/DL, 438MG/DL AND HI (>600MG/DL). QUALITY CONTROLS WERE RUN AND IN RANGE BUT WIFE WAS UNSURE OF THE OPENING DATE. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT 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 550502

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR SYNTHROID 0.088 MG/DAY - UNKNOWN YEARS| BABY ASPIRIN 81 MG/DAY - UNKNOWN YEARS| AMITRIPTYLINE/PERPHENAZINE - 25/2MG 2 PILLS 2X/DAY| NOVOLIN 70/30 25 UNITS PM - 10 YEARS| METROPROLOL 50MG 2X/DAY - UNKNOWN YEARS| NOVOLIN 70/30 30 UNITS AM - 10 YEARS| ZOLPIDEM 10MG 1/2 PILL/DAY - YEAR