BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF HEMATOLOGY ANALYZER

    MDR report key: 2873205 · Received December 13, 2012

    Report

    Report Number
    1061932-2012-02837
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K964988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BECKMAN FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER BY TELEPHONE. THE CUSTOMER REPORTED TO THE FSE THAT THEY WERE ABLE TO EFFECTUATE A REPAIR OF THE LEAK. THE CUSTOMER STATED THAT THE LEAK WAS CAUSED BECAUSE THE BATHS OF THE INSTRUMENT WERE OVERFLOWING. THE CUSTOMER REPLACED THE TUBING FOR THE DRAIN OF THE BATHS AND THE LEAK WAS REPAIRED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT A LEAK WAS FOUND INSIDE THE COULTER ACT DIFF HEMATOLOGY ANALYZER. THE LEAK WAS NOTED DURING START-UP WHILE THE CUSTOMER WAS TROUBLESHOOTING A VACUUM FAILURE. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT WHEN THE LEAK WAS FOUND. THERE WERE NO REPORTS OF INJURY OR EXPOSURES TO ANY LABORATORY PERSONNEL. NO ERRONEOUS RESULTS WERE GENERATED BY THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT DIFF HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1