BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTO LOADER

    MDR report key: 2827886 · Received November 12, 2012

    Report

    Report Number
    1061932-2012-02661
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT APPROXIMATELY 1 ML OF DILUTED BLOOD LEAKED FROM THE MANUAL PROBE OF THE COULTER HMX HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE INSTRUMENT HAD BEEN GENERATING R-FLAGS* ON CONTROL RESULTS. THE CUSTOMER WAS WEARING A LAB COAT, GLOVES, AND FACE PROTECTION AT THE TIME OF THE OCCURRENCE. THERE WAS NO INJURY OR EXPOSURE, AND MEDICAL ATTENTION WAS NOT SOUGHT. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. NO PATIENT RESULTS WERE AFFECTED BY THE LEAK. BEC FIELD SERVICE ENGINEER (FSE) OBSERVED THE LEAK WAS COMING FROM PROBE WIPE. THE PROBE WIPE WAS CATCHING ON THE PLATE BEHIND THE BSV (BLOOD SAMPLING VALVE) AND WAS NOT RETURNING COMPLETELY. THE FSE TIGHTENED THE PLATE SO THAT THE PROBE WIPE WAS NOT OBSTRUCTED, RESOLVING THE LEAK ISSUE. HOWEVER, THE FSE STATED THAT HE DID NOT OBSERVE AND COULD NOT DUPLICATE R-FLAGS ISSUE. SERVICE ACTIVITY PERFORMED WAS VERIFIED PER ESTABLISHED PROCEDURES, AND THE RESULTS MET PUBLISHED SPECIFICATIONS. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1