BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 684909 · Received March 7, 2006

    Report

    Report Number
    2243072-2006-00101
    Event Type
    Other
    Date Received
    March 7, 2006
    Date of Event
    February 9, 2006
    Report Date
    March 6, 2006
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED WITH ACCURACY ISSUE. BELIEVES HER CHILD IS GETTING HIGHER READINGS THAN THE WAY SHE FEELS. ANALYSIS RUN ON CONSENSUS ERROR GRID (CEG) USING COMPETITIVE MEAN READINGS (49) AS REFERENCE POINT VS. BD READINGS (200, 269) YIELDED SOME 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other