BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF2 HEMATOLOGY ANALYZER

    MDR report key: 3033821 · Received April 3, 2013

    Report

    Report Number
    1061932-2013-00546
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE CAUSE OF THE EVENT CAN BE ATTRIBUTED TO A PLUG IN THE DRAIN PATH. THE INSTRUMENT OPERATED AS INTENDED BY GENERATING MULTIPLE ERROR MESSAGES ALERTING THE OPERATOR TO AN INSTRUMENT PROBLEM. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE COULTER ACT DIFF2 HEMATOLOGY ANALYZER HAD APPROXIMATELY 50 ML FLUID OVERFLOWED FROM THE BATHS. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER ALSO STATED THAT THE ANALYZER GENERATED WHITE BLOOD CELL APERTURE ALERTS AND HEMOGLOBIN INCOMPLETE CALCULATIONS. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE, AND THERE WAS NO REPORT OF INJURY OR EXPOSURE TO WOUNDS OR MUCOUS MEMBRANES. THE CUSTOMER DID NOT REVIEW MATERIAL SAFETY DATA SHEET BUT HAS AN EXPOSURE CONTROL PLAN IN PLACE AT THE FACILITY. THERE WAS NO IMPACT TO PATIENT RESULTS OR TREATMENT. BECKMAN COULTER CUSTOMER TECHNICAL SPECIALIST (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING THE INSTRUMENT. THE CTS HAD THE CUSTOMER BLEACH THE BATHS AND APERTURES, BUT THE INSTRUMENT GENERATED VACUUM ERRORS AND "VACUUM ISOLATOR CHAMBER (VIC) IS FULL" MESSAGES. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE AND INSPECTED THE ANALYZER. THE FSE OBSERVED THAT THE FOAM TRAP WAS FULL, THE VACUUM ISOLATOR CHAMBER WAS NOT DRAINING AND THE BATHS WERE OVERFLOWING. THE FSE REPLACED THE VACUUM FILTER AND VACUUM ISOLATOR CHAMBER, AND EMPTIED THE FOAM TRAP JAR. THE FSE RAN STARTUP AND QUALITY CONTROL WITHOUT ANY LEAKING OR ERROR MESSAGES. THE FSE VERIFIED SERVICE ACTIVITY PERFORMED PER ESTABLISHED PROCEDURES, AND THE RESULTS MET THE PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136029 COULTER® ACT DIFF2 HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER ACT DIFF2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1