BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 597252 · Received June 18, 2004

    Report

    Report Number
    2243072-2004-00293
    Event Type
    Malfunction
    Date Received
    June 18, 2004
    Date of Event
    May 20, 2004
    Report Date
    June 18, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS THE REPLACEMENT METER IS GIVING TESTS RESULTA THAT ARE DIFFERENT. ANALYSIS RUN ON CLARK ERROR GRD USING MEAN AVERAGE READING (242) AS REF. POINT VS BD READINGS (288, 141, 297) YEILDED DATA POINTS IN THE D RANGE OF THE GRID, OUTSIDE ACCEPTABLE LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK BLOOD GLUCOSE MONITOR BD TEST STRIPS NBW BECTON DICKINSON NA 3064100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other