BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2970715 · Received February 20, 2013

    Report

    Report Number
    1061932-2013-00275
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE CONFIRMED THAT THE LEAK WAS AT THE FLOW CELL SAMPLE INPUT TUBING. THIS TUBING HAD BEEN DISCONNECTED FROM THE FITTING. THE SPECIFIC FITTING LOCATION WAS NOT PROVIDED BY THE FSE. THE FSE ALSO FOUND THAT THE FLOW CELL WAS CLOGGED. THE TUBING WAS REPLACED AND THE FLOW CELL CLOG WAS REMOVED BY BLEACHING. PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING A LEAK COMING FROM THE BOTTOM RIGHT SIDE OF THE COULTER LH 780 HEMATOLOGY ANALYZER OF ABOUT 50 ML. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE LEAK OCCURRED AFTER THE CUSTOMER COMPLETED STARTUP TESTS. THE CUSTOMER INITIALLY REPORTED RETICULOCYTE AND HEMOGLOBIN VOLTAGE ERRORS AFTER CHANGING DILUENT. THE BEC CUSTOMER TECHNICAL SUPPORT (CTS) INSTRUCTED THE CUSTOMER TO RUN A START-UP; THIS RESOLVED THE INITIAL START-UP FAILURE. THE CUSTOMER HOWEVER CALLED BACK AND REPORTED A LEAK AFTER THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74767 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1