BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2873168 · Received December 13, 2012

    Report

    Report Number
    1061932-2012-02820
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND EXAMINED THE SYSTEM. THE FSE FOUND THAT THE TUBING AT THE INPUT PORT (PORT 6) OF THE FLOW CELL HAD BECOME DISCONNECTED. THE FSE REPLACED THE TUBING. NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED. THE REPAIR WAS VERIFIED ACCORDING TO ESTABLISHED PROCEDURES AND THE RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER INC. (BEC) THAT WHILE RUNNING STARTUP, THERE WAS A LEAK OBSERVED UNDER THE COULTER LH 780 HEMATOLOGY ANALYZER. NO SYSTEM FLAGS OR ERRORS WERE GENERATED BY THE INSTRUMENT. THE VOLUME OF THE LEAK WAS APPROXIMATELY 5ML AND WAS NOT CONTAINED. NO ERRONEOUS RESULTS WERE GENERATED BY THE SYSTEM. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT. THERE WERE NO INJURIES OR EXPOSURES TO ANY LABORATORY PERSONNEL. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE 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