BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3942649 · Received July 17, 2014

    Report

    Report Number
    1061932-2014-01647
    Event Type
    Malfunction
    Date Received
    July 17, 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
    AZ, 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 OBSERVED THE TUBING ON THE FLOW CELL WAS DISCONNECTED. THE FSE RECONNECTED THE TUBING, RESOLVING THE LEAK; THE DIFFERENTIAL (DIFF) AND THE NUCLEATED RED BLOOD CELL (NRBC) ALSO PASSED UPON INSTRUMENT STARTUP. THE FSE PERFORMED INSTRUMENT VERIFICATION AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILING DIFFERENTIAL (DIFF) AND NUCLEATED RED BLOOD CELL (NRBC) AND LESS THAN 50 MLS OF BLUE FLUID LEAKED FROM THE RIGHT SIDE OF THE UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM ONTO THE COUNTER TOP. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES 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
    418406 UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1