BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF ANALYZER

    MDR report key: 2823381 · Received November 7, 2012

    Report

    Report Number
    1061932-2012-02645
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STARTUP AND CONTROLS WERE WITHIN RANGE PRIOR TO THE REPORTED EVENT. THE CUSTOMER STATED THAT CAT SAMPLES ARE PRONE TO CLOTS WHICH MAY HAVE CAUSED ONE OF THE BATHS TO OVERFLOW. BEC CUSTOMER TECHNICAL SPECIALIST (CTS) ASSISTED THE CUSTOMER OVER THE PHONE WITH PRIMING AND CLEARING THE APERTURES, RUNNING A RINSE/MIX FUNCTION, SWEEP FLOW AND PRIMING THE SYSTEM AGAIN. THE CUSTOMER THEN RAN STARTUP WHICH PASSED. THE CUSTOMER RERAN THE CAT SAMPLE AND RESULTS CORRELATED TO THE INITIAL RUN. THE BATH OVERFLOW HAS NOT RECURRED. A CLEAR CAUSE FOR THIS EVENT IS UNKNOWN HOWEVER FOLLOWING CTS TROUBLESHOOTING, THE ISSUE WAS RESOLVED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT APPROXIMATELY 2ML OF CLEAR FLUID WAS NOTICED UNDER THE BATH COVER OF THEIR COULTER ACT DIFF ANALYZER WHICH LEAKED ONTO THE COUNTER WHEN RUNNING AN ANIMAL (CAT) SAMPLE USING THE VETERINARY SOFTWARE OPTION. THE CUSTOMER STATED THERE WAS NO AFFECT TO RESULTS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED.

    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