BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 601384 · Received June 30, 2004

    Report

    Report Number
    2243072-2004-00340
    Event Type
    Other
    Date Received
    June 30, 2004
    Date of Event
    June 5, 2004
    Report Date
    June 30, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS GETTING VERY ERRATIC READINGS WHEN TESTING BACK TO BACK. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG. READING (183) AS REF POINT VS. BD READING (437, 224, 97, 85, 74) YIELDING SOME 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 3064362

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other