BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 584190 · Received March 15, 2005

    Report

    Report Number
    2243072-2005-00084
    Event Type
    Other
    Date Received
    March 15, 2005
    Date of Event
    February 16, 2005
    Report Date
    March 15, 2005
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CALLED TO REPORT COMPARING OLD METER WITH THE NEW ONE AND GETTING VERY DIFFERENT RESULTS. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG. READING (263) AS REF. POINT VS. BD READINGS OF 171, 308, 312 YIELDING DATA POINTS IN THE D ZONE 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 4064274

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other