BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX ANALYZER WITH AUTOLOADER

    MDR report key: 2342552 · Received November 18, 2011

    Report

    Report Number
    1061932-2011-02291
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 20, 2011
    Report Date
    October 20, 2011
    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 CALLED TO REPORT THAT THE COULTER HMX ANALYZER WITH AUTOLOADER WAS NOT GENERATING ANY DIFFERENTIAL RESULTS AND THAT THERE WAS A CLEAR FLUID LEAK UNDERNEATH THE INSTRUMENT. CUSTOMER STATED THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED, AND THAT NO ONE WAS HARMED BY OR EXPOSED TO THE LEAK. ON THE FOLLOWING DAY, THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT THE TUBING TO PINCH VALVE PV43 WAS CUT. THE FSE REPLACED THE TUBING AND PRIMED THE INSTRUMENT. THE FSE ALSO NOTICED THAT THE ABNORMAL II CONTROL WAS VOTING OUT DIFFERENTIAL RESULTS. THE FSE THEN REPLACED THE CONTROLS WITH A NEW LOT OF CONTROLS AND FOUND NO OTHER ISSUES. FINALLY, THE FSE VERIFIED INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1