BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3092958 · Received May 3, 2013

    Report

    Report Number
    1061932-2013-00746
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND FOUND WORN TUBING HAD POPPED OFF AT FEED-THRU FITTING (FF42). THE FSE INSTALLED A NEW TUBING TO RESOLVE THE LEAK AND THE DILUENT COMPARISON OUT OF LIMITS ERROR MESSAGES. FAILURE MODE: WORN TUBING POPPED OFF FEED-THRU FITTING (FF42). HOWEVER, THE INSTRUMENT GENERATED DILUENT COMPARISON ERRORS TO ALERT THE CUSTOMER TO AN INSTRUMENT PROBLEM. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) A DILUENT LEAK CONTAINED WITHIN THEIR COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE CUSTOMER STATED THE DILUENT COMPARISON ERRORS WERE GENERATED BY THE ANALYZER. THE INSTRUMENT WAS IDLE AT THE TIME OF THE LEAK. THE CUSTOMER WAS WEARING GOWN, GLOVES, AND GOGGLES. NO ONE WAS SPLASHED, SPRAYED OR INJURED. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. NO DEATH OR INJURY IS ATTRIBUTED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195329 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1