BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 5993550 · Received October 3, 2016

    Report

    Report Number
    1061932-2016-00868
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 15, 2016
    Report Date
    September 15, 2016
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K140911
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT. THE FSE FOUND THAT VALVE VL161 WAS FAULTY. THE FSE REPLACED THE VALVE, WHICH REPAIRED THE LEAK. THE REPAIRS WERE VERIFIED BY THE FSE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BLOODY LEAK FROM THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE VOLUME OF THE LEAK WAS NOT SPECIFIED AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE FSE WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, GOGGLES AND A LABORATORY COAT AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF INJURY OR BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO CHANGE IN PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646990 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1