BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2991894 · Received March 6, 2013

    Report

    Report Number
    1061932-2013-00364
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED FLUID LEAKED AT THE PROBE OF THE INSTRUMENT. THE FSE ALSO NOTED ERRATIC LATRON CONTROL VALUES. THE FSE REPLACED THE BLOOD SAMPLING VALVE (BSV) AND RESOLVED THE FLUID LEAK ISSUE. THE FSE REALIGNED THE FLOW CELL AND LATRON CONTROLS WERE WITHIN SPECIFICATIONS. THE FSE INDICATED THE FAILED LATRON CONTROLS WERE NOT RELATED TO THE FLUID LEAK. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRATIC LATRON CONTROLS AND APPROXIMATELY TEN DROPS OF DILUENT LEAKED AT THE BOTTOM OF THE INSTRUMENT FOLLOWING SYSTEM START-UP CYCLE INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT SAMPLES WERE NOT ANALYZED DURING THE EVENT. NO PATIENT RESULTS WERE GENERATED. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95425 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1