BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 716096 · Received July 29, 2005

    Report

    Report Number
    2243072-2005-00272
    Event Type
    Other
    Date Received
    July 29, 2005
    Date of Event
    July 2, 2005
    Report Date
    July 29, 2005
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT HER QUESTIONING THE ACCURACY OF HER METER. READINGS ARE VERY ERRATIC. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG READINGS (270) AS REFERENCE POINT VS. BD READINGS (385, 221, 223, 252, 277) YIELDED 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 4099145

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other