BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 594156 · Received June 11, 2004

    Report

    Report Number
    2243072-2004-00276
    Event Type
    Other
    Date Received
    June 11, 2004
    Date of Event
    May 17, 2004
    Report Date
    June 10, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED FOR FAMILY MEMBER. BLOOD SUGAR TESTED TODAY WITH HIGH RESULTS, NURSE RETESTED WITH ANOTHER METER AND RESULTS WERE NORMAL. ANALYSIS RUN ON CLARK ERROR GRID USING COMPETITIVE READING (122) AS REFERENCE POINT VS BD READING (574) YIELDED DATA POINTS IN THE C 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 3078055

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other