BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 513520 · Received January 20, 2004

    Report

    Report Number
    2243072-2004-00027
    Event Type
    Other
    Date Received
    January 20, 2004
    Date of Event
    December 22, 2003
    Report Date
    January 20, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER VERY UPSET WITH ERRATIC READINGS WITH PLINK METER. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVERAGE READING (57) AS REF. POINT VS. BD READINGS (26, 87) YIELDED READINGS IN THE "D" RANGE OF THE GRID, OUTSIDE ACCEPTABLE LIMITS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other