BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH780 HEMATOLOGY ANALYZER

    MDR report key: 2933793 · Received January 29, 2013

    Report

    Report Number
    1061932-2013-00087
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER THAT THE COULTER LH 780 HEMATOLOGY ANALYZER LEAKED APPROXIMATELY 7 ML OF FLUID BEHIND THE LASER ASSEMBLY. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. THERE WAS NO REPORT OF INJURY OR EXPOSURE, AND NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THEREFORE THERE WAS NO IMPACT TO PATIENT TREATMENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSISTED THE CUSTOMER OVER THE PHONE WITH TROUBLESHOOTING. SAMPLE LINE TO THE BOTTOM OF THE LASER HAD SLID DOWN ONTO THE FLOW CELL PORT. THE FSE HAD THE CUSTOMER TO REPOSITION TUBING ONTO THE PORT AND SECURE IT WITH A WIRE TIE, AND THIS RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38847 COULTER® LH780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1