BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC T 5DIFF AL

    MDR report key: 2873165 · Received December 13, 2012

    Report

    Report Number
    1061932-2012-02817
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K030291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND EXAMINED THE SYSTEM. THE FSE OBSERVED LIQUID FORMING ON TOP OF THE PROBE WIPE RINSE BLOCK. THE FSE FOUND THAT THE BOTTOM OF THE RINSE BLOCK WAS CRACKED. THE FSE REPLACED THE RINSE BLOCK AND THE LEAK WAS FIXED. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED A LEAK INSIDE THE COULTER AC-T 5DIFF AL ANALYZER. THE VOLUME OF THE LEAK WAS A FEW DROPS AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THERE WERE NO EXPOSURES OR INJURIES TO ANY LABORATORY PERSONNEL. NO ERRONEOUS RESULTS WERE GENERATED. THERE WERE NO CHANGES TO THE PATIENTS' CARE OR TREATMENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO EXAMINE THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® AC T 5DIFF AL COUNTER, DIFFERENTIAL CELL, GKZ BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1