BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 693476 · Received March 29, 2006

    Report

    Report Number
    2243072-2006-00129
    Event Type
    Other
    Date Received
    March 29, 2006
    Date of Event
    March 3, 2006
    Report Date
    March 27, 2006
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT READING OF 23 FOLLOWED BY A READING OF 220. FELT MORE LIKE TO THE 220 AND THINKS THE METER IS READING LOW. ANALYSIS RUN CONSENSUS ERROR GRID USING MEAN READING (122) AS REF POINT VS BD READINGS (23,220) YIELDED SOME DATA POINTS IN THE C ZONE OF THE GRID, OUTSIDE OF 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 5064111

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other