BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 483413 · Received September 9, 2003

    Report

    Report Number
    2243072-2003-00050
    Event Type
    Other
    Date Received
    September 9, 2003
    Date of Event
    August 8, 2003
    Report Date
    September 5, 2003
    Manufacturer
    BECTON DICKINSON
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER WAS FEELING THE BLOOD READINGS WERE WRONG, RAN COMPARISON AGAINST COMPETITIVE METER. ANALYSIS RUN ON CLARKE ERROR USING REPORTED COMPETITIVE READINGS (56) AS REF. POINT VS. BD READING (110, 118) YIELDED DATA POINTS IN "D" RANGE OF THE GRID, OUTSIDE ACCEPTABLE RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD LOGIC BLOOD GLUCOSE MONITOR BD TEST STRIPS CFR BECTON DICKINSON NA 1078360

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other