BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF ANALYZER

    MDR report key: 3822273 · Received May 20, 2014

    Report

    Report Number
    1061932-2014-01142
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND DISCOVERED THAT THE SOLENOID VALVE (LV8) WOULD NOT ACTIVATE. THE FSE PROCEEDED TO REPLACE THE SOLENOID LV8, AND CLEANED THE RINSE BLOCK TO RESOLVE THE LEAK. THE FSE VERIFIED THE REPAIR AS PER ESTABLISHED PROCEDURES AND NO FURTHER LEAKS WERE OBSERVED. FAILURE MODE OF THE EVENT IS ATTRIBUTED TO SOLENOID LV8 FAILURE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM THE PROBE OF THE COULTER ACT DIFF ANALYZER. THE CUSTOMER STATED THAT APPROXIMATELY 5 MILLILITERS OF FLUID LEAKED FROM THE PROBE WIPE AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR EXPOSURE. ERRONEOUS RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300725 COULTER AC*T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1