BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LOGIC (COBRANDED) BLOOD GLUCOSE METER

    MDR report key: 482665 · Received September 3, 2003

    Report

    Report Number
    2243072-2003-00042
    Event Type
    Other
    Date Received
    September 3, 2003
    Date of Event
    July 30, 2003
    Report Date
    August 29, 2003
    Manufacturer
    BECTON DICKINSON
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER QUESTIONING ACCURACY OF THE METER. ANALYSIS RUN ON CLARKE ERROR USING REPORTED LAB READINGS (57, 62, 42) AS REF. POINT VS. BD READING (200, 225, 290) YIELDED DATA POINTS IN "E" ZONE OF THE GIRD, OUTSIDE ACCEPTABLE RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD LOGIC (COBRANDED) BLOOD GLUCOSE METER BD TEST STRIPS CFR BECTON DICKINSON NA 3078041

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other