BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 720704 · Received May 25, 2006

    Report

    Report Number
    2243072-2006-00209
    Event Type
    Other
    Date Received
    May 25, 2006
    Date of Event
    May 4, 2006
    Report Date
    May 25, 2006
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT ERRATIC READINGS WITH HIS METER. ANALYSIS RUN ON CONSENSUS ERROR GRID USING MEAN READING (345) AS REF. POINT VS. BD READINGS (566, 137, 211, 466) YIELDED 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 5064301

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other