BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 12¿ ANALYZER

    MDR report key: 2871028 · Received December 12, 2012

    Report

    Report Number
    1061932-2012-02858
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED PINCH VALVE LV10, VACUUM PUMP, ASPIRATION PROBE, PROBE WIPE, AND VACUUM CHAMBER TO RESOLVE THE ISSUE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE UNIT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. WIPE, CHAMBER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY ONE MILLILITER OF CLEAR, COLORLESS DILUENT LEAKED FROM UNDERNEATH THE INSTRUMENT AND ONTO THE COUNTERTOP DURING THE RINSE PROCESS OF THE PROBE INVOLVING THE COULTER® ACT DIFF 12 ANALYZER. THE CUSTOMER WAS IN PREPARATION FOR QUALITY CONTROL (QC). PATIENT RESULTS WERE NOT GENERATED OR IMPACTED. THE CUSTOMER HAD ON PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. THE CUSTOMER PERFORMED TROUBLESHOOTING BUT THE ISSUE REMAINED. THERE IS A RISK MANAGEMENT PLAN AT THE FACILITY. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT DIFF 12¿ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1