BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2880671 · Received December 20, 2012

    Report

    Report Number
    1061932-2012-02843
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER INC. FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND EVALUATED THE SYSTEM. THE FSE FOUND A LEAKING ASPIRATION NEEDLE. THE FSE REMOVED AND REPLACED THE VENT LINE SENSOR TUBING THAT IS ATTACHED TO THE ASPIRATION NEEDLE. THE ISSUE WAS RESOLVED. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT THE MANUAL PROBE OF THE COULTER LH 780 HEMATOLOGY ANALYZER WAS LEAKING. APPROXIMATELY 6 ML OF DILUENT LEAKED ONTO THE WORKTOP AND THE FLOOR. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT. THERE ARE NO REPORTS OF ANY INJURIES OR EXPOSURES TO ANY LABORATORY PERSONNEL. NO ERRONEOUS RESULTS WERE GENERATED; ACCORDINGLY, THERE WERE NO CHANGES TO PATIENT CARE OR TREATMENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1