BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2¿ ANALYZER

    MDR report key: 2925914 · Received January 22, 2013

    Report

    Report Number
    1061932-2013-00108
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE VACUUM FILTER WAS WORN DUE TO WARE AND REPLACED THE VACUUM FILTER. THE FSE PERFORMED BACK-FLUSHED ON THE RED BLOOD CELL (RBC) APERTURE AND VERIFIED SWEEP FLOW RINSING. THE FSE PERFORMED APERTURE LATEX GAIN AND CLOG DETECTION ADJUSTMENTS AND REPRODUCIBILITY TEST; ALL RESULTS PASSED WITHIN SPECIFICATIONS. THE FSE VERIFIED SYSTEM STARTUP AND QUALITY CONTROL (QC) AND ALL PASSED WITHIN SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS PLATELET RESULTS, FOR TWO PATIENT SAMPLES, INVOLVING THE COULTER ACT DIFF 2 ANALYZER. THE CUSTOMER REANALYZED BOTH SAMPLES, ON THE SAME ANALYZER, TWO TIMES AND RECOVERED HIGHER RESULTS. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE PATIENT SAMPLES WERE ANALYZED IN CLOSED VIAL MODE AND APPEARED NORMAL. THE SAMPLES WERE APPROXIMATELY 20 MINUTES OLD BETWEEN COLLECTION AND ANALYSIS TIME. THE SAMPLES WERE COLLECTED IN AN ETHYLENEDIAMINETETRAACETIC ACID (EDTA) TUBE AS A VENIPUNCTURE FROM A CENTRAL LINE PORT. THE CUSTOMER PERFORMED A BACKGROUND AFTER THE EVENT TO VERIFY INSTRUMENT PERFORMANCE AND NOTED PLATELET FAILED. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31213 COULTER® ACT DIFF 2¿ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1