BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2¿ ANALYZER

    MDR report key: 2923507 · Received January 22, 2013

    Report

    Report Number
    1061932-2013-00075
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH TROUBLESHOOTING. THE INSTRUMENT WAS IN OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY TWENTY (20) MILLILITERS OF FLUID LEAKED AROUND THE INSTRUMENT AND ON THE TABLETOP AFTER THE FILTER WAS REPLACED DURING PREPARATION FOR CALIBRATION INVOLVING THE COULTER ACT DIFF 2 ANALYZER. THE CUSTOMER WAS ADVISED TO USE PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) PRIOR TO TROUBLESHOOTING AND HAD ON GLOVES, A LABORATORY COAT, AND EYE PROTECTION AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THE CUSTOMER DISCOVERED LOOSE TUBING AT THE WASTE FILTER AND REATTACHED THE TUBING TO RESOLVE THE ISSUE. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THE CUSTOMER HAS AN EXPOSURE CONTROL PLAN AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31073 COULTER® ACT DIFF 2¿ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1