BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4509253 · Received February 11, 2015

    Report

    Report Number
    1061932-2015-00217
    Event Type
    Malfunction
    Date Received
    February 11, 2015
    Date of Event
    January 14, 2015
    Report Date
    January 14, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K140911
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 01/15/2015. THE FSE OBSERVED AN ABNORMAL DIFF PATTERN ON ONE SAMPLE WHILE ONSITE. THE FSE FOUND DISCONNECTED TUBING AT PORT 2 ON THE DISTRIBUTION VALVE (DV). THE FSE DID NOT FIND ANY OTHER INSTRUMENT FAILURE AND DEDUCED THAT THE DIFFERENTIAL ISSUES WERE RESULTING FROM THE DISCONNECTED TUBING THAT CAUSED THE LEAK. THE FSE REPLACED THE TUBE ONTO THE DV PORT 2, RESOLVING THE LEAK. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ONGOING FLUID LEAK FROM A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE LEAK WAS NOT CONTAINED. THE CUSTOMER ALSO REPORTED THAT THERE WERE INCOMPLETE AND OVER-RANGE DIFF RESULTS (.../++++) ON PATIENT SAMPLE(S) RUN ON THE INSTRUMENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA FOR REVIEW. THE CUSTOMER PERFORMED MANUAL DIFFERENTIAL ON ALL SAMPLES THAT WERE AFFECTED WHILE THE LEAK WAS ONGOING. 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
    100750 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1