BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER CZE 2000 SYSTEM

    MDR report key: 252143 · Received November 23, 1999

    Report

    Report Number
    2050012-1999-00005
    Event Type
    Malfunction
    Date Received
    November 23, 1999
    Date of Event
    October 11, 1999
    Report Date
    November 18, 1999
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JZS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT A SIGNIFICANT IGG KAPPA MONOCLONAL PROTEIN WAS NOT IDENTIFIED ON APT WHEN USING THE CZE ELECTROPHORESIS SYSTEM. WHEN RERUN USING THE PARAGON GEL ELECTROPHORESIS SYSTEM, THE MONOCLONAL FRACTION WAS IDENTIFIED. THE CZE SYSTEM LABELING DESCRIBES THE POTENTIAL FOR THE SYSTEM TO MISS A SMALL MONOCLONAL FRACTIONS. MONOCLONAL PROTEINS MAY BE INDICATIVE OF SERIOUS ILLNESS AND DISEASE STATES AND A SIGNIFICANT MONOCLONAL THAT IS NOT IDENTIFIED COULD LEAD TO INCORRECT DIAGNOSIS OR INAPPROPRIATE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER CZE 2000 SYSTEM COLUMN ELECTROPHORESIS SYSTEM JZS BECKMAN COULTER, INC. CZE 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *