BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2¿ ANALYZER

    MDR report key: 2880675 · Received December 20, 2012

    Report

    Report Number
    1061932-2012-02844
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ON-SITE FIELD SERVICE CALL WAS INITIATED. BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) GUIDED THE CUSTOMER TO USE THE SYSTEM DILUTER FUNCTIONS TO REMOVE A CLOT FROM THE OVERFLOWING BATH. ONCE THE CLOT WAS REMOVED, THE CUSTOMER TESTED THE SYSTEM TO ASSURE THAT THE WHITE BLOOD CELL BATH WAS FILLING AND DRAINING CORRECTLY. SYSTEM START-UP WAS PERFORMED AND PASSED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT A FEW MILLILITERS OF FLUID LEAKED FROM THE OVERFLOWING WBC (WHITE BLOOD CELL) BATH OF THE COULTER ACT DIFF 2 ANALYZER. THE CUSTOMER OPENED THE INSTRUMENT AND CONFIRMED THE WBC BATH WAS OVERFILLED AND OVERFLOWING. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THERE IS NO REPORTS OF ANY INJURIES OR EXPOSURES TO ANY LABORATORY PERSONNEL. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1