BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 646049 · Received September 30, 2005

    Report

    Report Number
    2243072-2005-00371
    Event Type
    Other
    Date Received
    September 30, 2005
    Date of Event
    September 3, 2005
    Report Date
    September 29, 2005
    Manufacturer
    BECTON DICKINSON
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    METER GIVING VERY DIFFERENT READINGS. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG READING (56) AS REFERENCE POINT VS BD READINGS (74, 73, 21) 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 CFR BECTON DICKINSON NA 3064300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other