BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF ANALYZER

    MDR report key: 3100857 · Received May 8, 2013

    Report

    Report Number
    1061932-2013-00734
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CTS (CUSTOMER TECHNICAL SUPPORT) PERFORMED TROUBLESHOOTING OVER THE PHONE. AFTER THE CUSTOMER RECEIVED THE 'LOW DILUENT' ERROR, CTS INSTRUCTED THE CUSTOMER TO REBOOT THE INSTRUMENT IN BYPASS MODE. THE DILUENT FILTERS WERE BYPASSED AND THE RESERVOIRS FILLED UP. THE CUSTOMER THEN REPLACED THE FILTERS (WHICH RESOLVED THE 'LOW DILUENT' ERROR MESSAGE) AND REBOOTED. THERE WAS A 'LOW LYSE' ERROR MESSAGE GENERATED, FOLLOWING THE REBOOT ALONG WITH FAILED PLATELETS. THE LYSE AND SWEEPFLOW WERE THEN PRIMED. THE SUBSEQUENT STARTUP PERFORMED PASSED. THE CAUSE OF THE PROBE LEAK MAY BE ATTRIBUTED TO AN OVERFLOW OF DILUENT FROM THE DILUENT FILTERS. THE PLATELET FAILURES MAY ALSO BE RELATED TO THE DILUENT FILTER. THE LYSE ERROR WAS RESOLVED AFTER PRIMING AND WAS NOT RELATED TO THE DILUENT LEAK AND DILUENT ERROR MESSAGE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT A FLUID LEAK FROM THE PROBE OF A COULTER ACT DIFF ANALYZER. THE VOLUME OF THE LEAK WAS UNKNOWN. THE INSTRUMENT GENERATED 'LOW DILUENT' ERROR. THE CUSTOMER WAS WEARING GLOVES AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED. THERE WAS NO AFFECT TO PATIENT SAMPLES. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201530 COULTER® ACT DIFF ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER ACT DIFF NA

    Patients

    Seq Age Sex Outcome Treatment
    1