BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4624915 · Received March 23, 2015

    Report

    Report Number
    1061932-2015-00514
    Event Type
    Malfunction
    Date Received
    March 23, 2015
    Date of Event
    March 1, 2015
    Report Date
    March 1, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K140911
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 03/02/2015. THE FSE CONFIRMED A SMALL AMOUNT OF FLUID ON THE SAMPLE CAPS, CAUSED BY A LEAK FROM THE PROBE WASH COLLAR DUE TO A BENT SAMPLE PROBE. THE SAMPLE PROBE WAS REPLACED, RESOLVING THE LEAK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CLEAR FLUID LEAK OF APPROXIMATELY 0.2ML FROM THE PROBE RINSE BLOCK ON A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT AND SPECIMEN TUBE CAPS ALSO APPEARED TO BE WET. NO ERROR MESSAGES WERE OBSERVED BY THE CUSTOMER AT THE TIME OF THE EVENT. THE INSTRUMENT WAS CONSIDERED INOPERABLE UNTIL SERVICE COULD EVALUATE THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192903 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1