BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 661696 · Received January 9, 2006

    Report

    Report Number
    2243072-2006-00013
    Event Type
    Other
    Date Received
    January 9, 2006
    Date of Event
    December 11, 2005
    Report Date
    January 6, 2006
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT HER METER GIVING INACCURATE READINGS - GETTING SOME LOW READINGS. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVERAGE READING (243) AS REFERENCE POINT VS BD READINGS (489, 128, 111) 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 4064328

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other