BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 516348 · Received January 28, 2004

    Report

    Report Number
    2243072-2004-00045
    Event Type
    Other
    Date Received
    January 28, 2004
    Date of Event
    January 2, 2004
    Report Date
    January 27, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS MULTIPLE PROBLEM WITH METER, INCLUDING ACCURACY ISSUES. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG READING (285) AS REF. POINTS VS. BD READINGS (120, 450) YIELDED DATA POINTS IN 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 3064083

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other