BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 610862 · Received July 9, 2004

    Report

    Report Number
    2243072-2004-00357
    Event Type
    Other
    Date Received
    July 9, 2004
    Date of Event
    June 9, 2004
    Report Date
    July 8, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS GETTING ERRATIC READINGS WITH THEIR PLINK METER. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG. READING (231, 181) VS. BD READINGS (96, 366; 301,61) YIELDED DATA POINT5S IN THE C/E 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 3064023

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other