BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LOGIC BLOOD GLUCOSE METER

    MDR report key: 617338 · Received August 5, 2004

    Report

    Report Number
    2243072-2004-00448
    Event Type
    Other
    Date Received
    August 5, 2004
    Date of Event
    July 8, 2004
    Report Date
    August 4, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED WITH CONCERNS ON ACCURACY. THEY REPORT THEIR SPOUSE IS COMPARING METER TO METER RESULTS. ANALYSIS RUN ON CLARK ERROR GRID USING COMPETITIVE READING (140, 134) AS REF. POINT VS. BD READINGS (288, 206) YIELDED DATA POINTS IN THE C RANGE OF THE GRID, OUTSIDE OF ACCEPTABLE LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD LOGIC BLOOD GLUCOSE METER BD TEST STRIPS NBW BECTON DICKINSON NA 3064282

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other