BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 619053 · Received August 13, 2004

    Report

    Report Number
    2243072-2004-00471
    Event Type
    Other
    Date Received
    August 13, 2004
    Date of Event
    July 14, 2004
    Report Date
    August 13, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS INACCURATE REUSLTS WITH THEIR METER. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG. READINGS (234) AS REF. POINT VS. BD READINGS (74, 365, 262) YIELDED DATA POINTS IN THE C RANE OF THE GRID, OUTSIDE OF 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 3064100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other