BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF ANALYZER

    MDR report key: 2334167 · Received November 12, 2011

    Report

    Report Number
    1061932-2011-02159
    Event Type
    Malfunction
    Date Received
    November 12, 2011
    Date of Event
    October 14, 2011
    Report Date
    October 14, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, BEC CTS (CUSTOMER TECHNICAL SUPPORT) HAD THE CUSTOMER INSPECT THE RINSE BLOCK AND TUBING. THE CUSTOMER FOUND AND REMOVED A CLOT AND THEN RAN STARTUP AND SAMPLE TESTED COMPARED TO PREVIOUS RUN. SERVICE WAS NOT DISPATCHED. WHEN THE CUSTOMER CALLED BACK ON (B)(6) 2011 WITH REGARD TO THE WBC BATH NOT DRAINING USING DILUTER FUNCTIONS, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE AND FOUND A CLOT IN THE SYSTEM UPON WHICH FSE REPLACED THE WBC BATH AND DRAIN SOLENOID VALVE. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. THE ROOT CAUSE FOR THIS EVENT IS ATTRIBUTED TO THE CLOT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE WBC BATH IN THE COULTER ACT DIFF ANALYZER WAS NOT DRAINING AND WAS OVERFLOWING ONTO THE COUNTER. THE OPERATOR WAS WEARING GLOVES AND A LAB COAT AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED AND MEDICAL ATTENTION WAS NOT SOUGHT. THE CUSTOMER HAD CALLED BEC A DAY BEFORE THIS LEAK ((B)(6) 2011) STATING THAT THE INSTRUMENT WAS DRIPPING FROM THE PROBE (THIS EVENT HAS BEEN DOCUMENTED IN A SEPARATE MDR REPORT #1061932-2011-02158).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1