BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX ANALYZER WITH AUTOLOADER

    MDR report key: 2895379 · Received January 3, 2013

    Report

    Report Number
    1061932-2012-02912
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A LIQUID LEAK FROM THE FRONT OF THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. CUSTOMER REPORTED THAT CLEANING FLUID STREAKED WITH BLOOD WAS DRIPPING FROM THE MANUAL MODE PROBE. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) TIGHTENED THE BLOOD SAMPLING VALVE KNOB THAT WAS LOOSE AND RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034 COULTER HMX ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1