BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 495952 · Received November 6, 2003

    Report

    Report Number
    2243072-2003-00092
    Event Type
    Other
    Date Received
    November 6, 2003
    Date of Event
    October 6, 2003
    Report Date
    November 5, 2003
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS GETTING INACCURATE READINGS ON FAMILY MEMBER'S PARADIGM LINK METER. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVERAGE (50) VS. BD READINGS (22, 77, 74) YIELDED DATA POINTS IN THE "A/D" RANGE OF THE GRID - OUTSIDE ACCEPTABLE RANGE.

    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 3064062

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other