BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 1890377 · Received November 3, 2010

    Report

    Report Number
    2050012-2010-01146
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K962294
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(4) 2010. THE CUSTOMER INFORMED THE FSE THAT THE SYSTEM HAD A PLUG IN THE SAMPLE WASH CUP EARLIER THE DAY AND IT WAS FLUSHED OUT WITH BLEACH. THE FSE REPLACED THE CUVETTE WASH LINE FILTER AS A PRECAUTION. THE FSE FLUSHED THE LINE AND WASHED ALL CUVETTES. THE SYSTEM IS NOW OPERATING ACCEPTABLY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO DRIED WASH SOLUTION OBSERVED UNDER IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. NO OPERATOR EXPOSURE WAS NOTED. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM CLINICAL IMMUNOCHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. IMMAGE 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1