BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 887972 · Received October 14, 2004

    Report

    Report Number
    2243072-2004-00636
    Event Type
    Malfunction
    Date Received
    October 14, 2004
    Date of Event
    September 13, 2004
    Report Date
    October 13, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING PRODUCT RETURN TO CONDUCT QUALITY INVESTIGATION.

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT GETTING INACCURATE READINGS ON HER PLINK METER. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG. READINGS (173) AS REF. POINT VS. BD READINGS (27, 232, 261) YIELDED DATA POINTS IN THE C RANGE 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 4064062

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other