BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3982401 · Received August 6, 2014

    Report

    Report Number
    1061932-2014-01833
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 CONFIRMED THE SAMPLE LINE (TUBING) HAD BECOME DISCONNECTED FROM THE BOTTOM OF THE FLOWCELL CAUSING A SMALL CONTAINED LEAK. THE VOLUME OF THE LEAK WAS UNKNOWN. THE FSE REPLACED THE SAMPLE LINE (TUBING), RESOLVING THE LEAK, INCOMPLETE RESULTS, AND ERRORS. THE FSE ALSO BLEACHED THE FLOWCELL WASTE PATHWAY AS PART OF TROUBLESHOOTING. WHILE ONSITE, THE FSE OBSERVED THE LEAK HAD DAMAGED THE MEDIAN ANGLE LIGHT SCATTER (MALS) SENSOR CAUSING ERRATIC OFFSETS. THE FSE REPLACED THE MALS SENSOR, RESOLVING THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED INCOMPLETE RESULTS FOR THE DIFFERENTIAL (DIFF) AND NUCLEATED RED BLOOD CELL (NRBC). THE CUSTOMER ALSO REPORTED THE INSTRUMENT GENERATED 'LOW EVENT RATE' ERRORS. THERE WAS NO REPORTED EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE INCIDENT. THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY. THERE WAS NO DEATH, INJURY, OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460654 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1