BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4592571 · Received March 11, 2015

    Report

    Report Number
    1061932-2015-00436
    Event Type
    Malfunction
    Date Received
    March 11, 2015
    Date of Event
    February 14, 2015
    Report Date
    February 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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON (B)(4) 2015. THE FSE CONFIRMED ASPIRATION "P" ERRORS ON MAP (MICROTUBE DEVICE FOR AUTOMATED PROCESS) PEDIATRIC TUBES. THE FSE RESOLVED THIS ISSUE BY REPLACING THE SAM (SAMPLE ASPIRATION MODULE) RIBBON CABLE AND THE STRIPPER MOTOR; NO FURTHER PROBLEMS WITH PARTIAL ASPIRATION ERRORS WERE OBSERVED AFTER THOSE TWO PARTS WERE REPLACED. UNRELATED TO THE ASPIRATION ERRORS, THE HEMOGLOBIN (HGB) CHAMBER ASSEMBLY WAS REPLACED DUE TO A CLOUDY APPEARANCE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECOVERING PARTIAL ASPIRATION ERRORS ON PEDIATRIC TUBES RUN IN AUTOMATED MODE ON A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. BASIC TROUBLESHOOTING WITH THE HELP OF CUSTOMER TECHNICAL SUPPORT (CTS) VIA PHONE FAILED TO IDENTIFY THE SOURCE OF THE PROBLEM, AND A SERVICE VISIT WAS REQUESTED. 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
    169479 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1