BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3945171 · Received July 18, 2014

    Report

    Report Number
    1061932-2014-01649
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K120771
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE STATED THAT THE ISSUE OCCURRED ON CONTROLS ONLY; PATIENT SAMPLES WERE NOT CYCLED ON THE INSTRUMENT DURING THE EVENT. THE FSE CONFIRMED QUICK DISCONNECT (QD 281) IN THE VOLUME, CONDUCTIVITY, SCATTER (VCS) PANEL WAS LOOSE CAUSING APPROXIMATELY 5 MLS OF SHEATH FLUID TO LEAK INSIDE THE ANALYSIS SYSTEM. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE FSE TIGHTENED THE QUICK DISCONNECT, RESOLVING THE LEAK AND INCOMPLETE DIFFERENTIAL RESULTS. THE FSE PERFORMED INSTRUMENT VERIFICATION AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM GENERATING AN INCOMPLETE DIFFERENTIAL RESULTS ON CONTROLS. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, GOGGLES AND A LAB COAT AT THE TIME OF THE INCIDENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422565 UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1