BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 1971259 · Received January 26, 2011

    Report

    Report Number
    2050012-2011-00261
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K962294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2010 AND REPLACED THE FILTER, FLUSHED THE TUBING AND PROBE WASH. A CHIP OF PAINT WAS FOUND IN THE PROBE WASH AND THIS ISSUE HAS BEEN RESOLVED. CUSTOMER RAN QC AND PATIENT SAMPLES WITH NO ERRORS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE SAMPLE PROBE WAS FLOODING IN THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. NO OPERATOR EXPOSURE WAS NOTED FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1