BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2079517 · Received May 6, 2011

    Report

    Report Number
    1061932-2011-00346
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE REALIGNED PROBE WASH COLLAR AND VERIFIED THE SYSTEM'S OPERATION.

    Description of Event or Problem · 1

    THE ORIGINAL REPORT PROVIDED BY THE BECKMAN COULTER PRODUCT SPECIALIST STATED THAT THERE WAS BLOOD ON THE TOP OF TUBES, "MAX # SAM" ERRORS, AND BLOOD IN PROBE WASH COLLAR ON THE UNICEL DXH 800 COULTER INSTRUMENT. PER FOLLOW UP WITH THE PRODUCT SPECIALIST, BLOOD WAS MISTAKENLY REPORTED, BUT CLEANER WAS OBSERVED AT THE END OF THE SHUTDOWN CYCLE AND UNDER THE PROBE WASH COLLAR. THE FLUID WAS TRANSFERRED TO THE TOPS OF THE FIRST FEW SAMPLE TUBES AND NOT THE BASE ON SAMPLE TRANSPORT MODULE (STM) WHICH INTERFERED WITH MOVEMENT OF THE CASSETTES. THE OPERATOR WAS WEARING LAB COAT, GLOVES, AND EYE PROTECTION IN ASSOCIATION WITH THIS EVENT. THERE WERE NO REPORTS OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT. NO ONE SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1