BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF ANALYZER

    MDR report key: 2990795 · Received March 5, 2013

    Report

    Report Number
    1061932-2013-00355
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LV7 IS A THREE-WAY SOLENOID VALVE USED TO ROUTE DILUENT DISPENSED BY THE SAMPLE SYRINGE VIA LV11 TO THE LOWER-SIDE PORTS OF THE BATHS. LV11 IS A THREE-WAY SOLENOID VALVE USED TO CONTROL DILUENT OUTPUT FROM THE SAMPLE SYRINGE. LV12 IS A THREE-WAY SOLENOID VALVE USED TO CONTROL THE ROUTING OF DILUENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF DILUENT INVOLVING THE COULTER ACT DIFF ANALYZER. THE CUSTOMER INDICATED THAT THE LEAK WAS APPROXIMATELY 10 ML IN VOLUME AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2013 AND NOTED THAT THERE WAS A FLUID LEAK BUT WAS UNABLE TO FIND THE SOURCE OF THE LEAK. THE FSE REPLACED THE PINCH VALVES FOR LV12, LV11, AND LV7 AS A PREVENTIVE MEASURE. THE FSE THEN PERFORMED INSTRUMENT STARTUP AND RAN QUALITY CONTROL (QC) WITHOUT ANY FURTHER LEAKS. THE CUSTOMER HAS NOT REPORTED A RECURRENCE OF THIS EVENT AS OF (B)(6) 2013. FAILURE MODE WAS DETERMINED TO BE ONE, OR A COMBINATION OF THE PINCH VALVES REPLACED DURING SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92850 COULTER® AC*T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1