BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2930761 · Received January 28, 2013

    Report

    Report Number
    1061932-2013-00038
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND CONFIRMED A LEAK FROM A WORN RBC BATH. FSE REPLACED THE RBC BATH AND APERTURE WHICH RESOLVED THE LEAK. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE LEAK WAS A WORN RBC BATH. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT 3ML OF CLEAR FLUID HAD LEAKED FROM THE FRONT PANEL AND DOWN THE MANUAL PROBE OF THEIR COULTER LH 500 HEMATOLOGY ANALYZER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT AND GLOVES AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED. THE INSTRUMENT WAS COMPLETING A DILUENT PRIME CYCLE WHEN THE LEAK WAS DISCOVERED, THEREFORE, SAMPLES WERE NOT BEING PROCESSED AT THE TIME OF THE EVENT. THERE WERE NO ERRONEOUS RESULTS EITHER GENERATED OR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36615 COULTER® LH 500 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1