BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 668755 · Received September 13, 2005

    Report

    Report Number
    2243072-2005-00351
    Event Type
    Other
    Date Received
    September 13, 2005
    Date of Event
    August 19, 2005
    Report Date
    September 12, 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

    METER RUNING VERY HIGH. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVERAGE READING - (228) AS REFERENCE POINT VS BD READINGS (347, 74, 239, 223) YIELDED SOME DATA POINTS IN THE C RANGE THE GRID, OUTSIDE ACCEPTABLE LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD LOGIC BLOOD GLUCOSE MONITOR BD TEST STRIPS NBW BECTON DICKINSON NA 3064338

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other