BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 5108539 · Received September 28, 2015

    Report

    Report Number
    1061932-2015-01526
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Date of Event
    September 9, 2015
    Report Date
    September 9, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K140911
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 09/10/2015 AND CONFIRMED THAT THE CUSTOMER RESOLVED THE ISSUE REPLACING DISCONNECTED TUBING AT THE DIFF MIX CHAMBER (MC240) RESOLVING THE REPORTED LEAK AND FLAGS RECOVERED BY THE INSTRUMENT. THE BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 3ML OF CLEAR FLUID LEAKED FROM A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER ALSO REPORTED DIFFERENTIAL (DIFF) VOTE OUTS ON PATIENT SAMPLES WITH EXCESSIVE DEBRIS, HIGH EVENT D AND IMM GRANS FLAGS AT THE TIME OF THE EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LABORATORY COAT, GOGGLES 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 REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THERE WAS NO IMPACT TO CONTROLS. THE CUSTOMER STATED ALL PATIENT SAMPLES WERE RE-RUN ON THE LAB'S BACK UP UNIT OBTAINING CORRECT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639347 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1