BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 5105696 · Received September 25, 2015

    Report

    Report Number
    1061932-2015-01464
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Date of Event
    September 11, 2015
    Report Date
    September 11, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K140911
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015, THE FIELD SERVICE ENGINEER (FSE) FOUND A LEAK THROUGH THE PROBE WASH BLOCK DURING SHUTDOWN. THE FSE REPLACED THE PROBE WASH BLOCK TO FIX THE LEAK. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNCONTAINED CLEANER LEAK OF ABOUT 1 ML FROM THE DXH 800 DURING SHUTDOWN. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LABORATORY COAT, EYE GLASSES AND GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THERE WAS NO IMPACT TO PATIENT RESULTS AND CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637174 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER

    Patients

    Seq Age Sex Outcome Treatment
    1