BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD COBRANDED LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 518365 · Received February 5, 2004

    Report

    Report Number
    2243072-2004-00059
    Event Type
    Other
    Date Received
    February 5, 2004
    Date of Event
    January 7, 2004
    Report Date
    February 4, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER QUESTIONING ACCURACY OF THEIR METER WHEN COMPARING TO A LAB TEST. ANALYSIS RUN ON CLARK ERROR GRID USING LAB READING (111,106) AS REF. POINT VS. BD READING (287,263) YIELDED DATA POINT IN THE C RANGE OF THE GRID, OUTSIDE ACCEPTABLE LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD COBRANDED LOGIC BLOOD GLUCOSE MONITOR BD TEST STRIPS CFR BECTON DICKINSON NA 2078288

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other