BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 666778 · Received January 19, 2006

    Report

    Report Number
    2243072-2006-00019
    Event Type
    Other
    Date Received
    January 19, 2006
    Date of Event
    December 18, 2005
    Report Date
    January 17, 2006
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT METER GIVING VARIOUS READINGS. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVERAGE READINGS (360) AS REFERENCE POINT VS. BD READINGS (120, 600) YIELDED SOME DATA POINTS IN THE C/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 5064035

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other