BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX ANALYZER WITH AUTOLOADER

    MDR report key: 2897349 · Received January 4, 2013

    Report

    Report Number
    1061932-2013-00013
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. THAT APPROXIMATELY 3 ML OF DILUENT FLUID LEAKED FROM THE MANUAL SAMPLE PROBE OF THE COULTER HMX ANALYZER WITH AUTOLOADER WHILE RUNNING LATRON QUALITY CONTROL. CUSTOMER REPORTED THE LEAK WAS FROM THE BLOOD SAMPLING VALVE OF THE MANUAL SAMPLING PROBE. CUSTOMER REPORTED THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. CUSTOMER REPORTED PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE TO EVALUATE THE INSTRUMENT. THE FSE FOUND THAT THE PROBE WIPE RINSE BLOCK WAS NOT GOING ALL THE WAY DOWN. THE FSE FOUND A SCREW WAS MISSING FROM THE RINSE BLOCK. THE FSE REPLACED THE SCREW AND THE LEAK WAS RESOLVED. CUSTOMER INDICATED TO THE FSE THAT THE INSTRUMENT HAD GIVEN "HGB LAMP VOLTAGE LOW" ERRORS WHEN RUNNING CONTROLS. THE CUSTOMER REPORTED THEY ADJUSTED THE HGB LAMP. THE FSE FOUND THE INSTRUMENT WAS RUNNING WITHOUT ANY ERRORS WHEN HE ARRIVED AT THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4416 COULTER HMX ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1