BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 578856 · Received February 22, 2005

    Report

    Report Number
    2243072-2005-00044
    Event Type
    Other
    Date Received
    February 22, 2005
    Date of Event
    January 22, 2005
    Report Date
    February 18, 2005
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT ACCURACY ISSUES WITH THEIR METER. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVERAGE READING (165) AS REF. POINT VS. BD READINGS OF 280, 74, 140 YIELDED DATA POINTS IN THE C ZONE OF THE GRID, OUTSIDE OF 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