BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 533474 · Received March 10, 2004

    Report

    Report Number
    2243072-2004-00144
    Event Type
    Other
    Date Received
    March 10, 2004
    Date of Event
    February 10, 2004
    Report Date
    March 9, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS TAKING 4 READINGS IN A ROW (W/ BD LOGIC) AND GETTING VERY DIFFERENT READINGS. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVERAGE READINGS (262) AS REF. POINT VS. BD READINGS 162, 302, 287, 295 YIELDED SOME DATA POINTS IN THE D RANGE OF 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 3064023

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other