BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE METER

    MDR report key: 612866 · Received July 20, 2004

    Report

    Report Number
    2243072-2004-00407
    Event Type
    Other
    Date Received
    July 20, 2004
    Date of Event
    June 25, 2004
    Report Date
    July 19, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS READINGS THAT ARE NOT CONSISTENT WITH THE WAY THEY FEEL. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG. READINGS. (263) AS REF. POINT VS. BD READINGS (20, 596, 230, 270, 198) YIELDED DATA POINTS IN THE C/E RANGE OF THE GRID, OUTSIDE OF ACCEPTABLE LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK BLOOD GLUCOSE METER BD TEST STRIPS CFR BECTON DICKINSON NA 3064023

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other