BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX ANALYZER WITH AUTOLOADER

    MDR report key: 2805230 · Received October 25, 2012

    Report

    Report Number
    1061932-2012-02597
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 30, 2012
    Report Date
    September 30, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 THE COULTER HMX ANALYZER WITH AUTOLOADER (HMX) GAVE AMBIENT TEMP ERRORS AND ALSO THERE WAS A CLENZ LEAK ON THE RIGHT HAND SIDE AREA OF THE HMX ANALYZER. THERE WAS NO REPORT OF PATIENT RESULTS AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE CUT TUBING (THAT WAS EITHER PINCHED OR WORN) THROUGH PINCH VALVE PV48 AND RESOLVED THE LEAK ISSUE. THE FSE DID NOT OBSERVE ANY ERROR MESSAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1