BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 564730 · Received January 6, 2005

    Report

    Report Number
    2243072-2005-00008
    Event Type
    Other
    Date Received
    January 6, 2005
    Date of Event
    December 16, 2004
    Report Date
    January 6, 2005
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED TO NUMEROUS ERRONEOUS READINGS WITH THEIR METER. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG. READING (282) VS. BD READINGS OF 521, 408, 166, 161, 155 YIELDED DATA POINTS IN THE C/D ZONE OF THR 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other