BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3801288 · Received May 8, 2014

    Report

    Report Number
    1061932-2014-01017
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE FOUND CLEANER HAD LEAKED BELOW THE AMTC [AIR MIX AND TEMPERATURE CONTROL] AREA FROM THE PROBE WASH COLLAR. HE REMOVED AND CLEANED THE PROBE WASH COLLAR, THEN REINSTALLED AND ALIGNED IT. THIS RESOLVED THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 2 TO 3 DROPS OF DILUENT MIXED WITH BLOOD ON THE CAPS OF TUBES AFTER RUNNING THEM ON THE DXH 800 INSTRUMENT. THE LEAK WAS CONTAINED WITHIN THE UNIT. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278693 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1