BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 560477 · Received May 13, 2004

    Report

    Report Number
    2243072-2004-00225
    Event Type
    Other
    Date Received
    May 13, 2004
    Date of Event
    April 13, 2004
    Report Date
    May 12, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT RECEIVING READINGS SOMETIMES 100 POINTS HIGHER THAN THEIR OTHER METER. UNSURE WHICH IS CORRECT, BUT FEELS THE OTHER METER IS MORE ACCURATE TO THE WAY THEY FEEL. ANALYSIS RUN ON CLARK ERROR GRID USING COMPETITIVE READING (143, 130, 130) AS REF. POINT VS. BD READING (289, 269, 239) YIELDED DATA POINTS IN THE C 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 3064282

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other