BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 510780 · Received January 15, 2004

    Report

    Report Number
    2243072-2004-00015
    Event Type
    Other
    Date Received
    January 15, 2004
    Date of Event
    December 18, 2003
    Report Date
    January 14, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS TESTING THEIR BD METER AGAINST A LABORATORY METER. ANALYSIS RUN ON CLARK ERROR GRID USING LAB READING (49) AS REF. POINT VS. BD READINGS (74) YIELDED READINGS 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 3064079

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other