BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF 2 ANALYZER

    MDR report key: 3011816 · Received March 19, 2013

    Report

    Report Number
    1061932-2013-00423
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBSERVING A SMALL AMOUNT OF FLUID ON THE TOP EDGE OF THE WHITE BLOOD CELL (WBC) BATH OF THE COULTER ACT DIFF 2 ANALYZER WHILE TROUBLESHOOTING FOR PLATELETS (PLT) FAILING CARRYOVER ERRORS. THE CUSTOMER INDICATED THAT THE FLUID WAS LOCATED WHERE THE DILUENT DELIVERY TUBE IS AND THE VOLUME OF FLUID WAS ONE OR TWO DROPS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES AND NO EXPOSURE OR INJURY WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) NOTED PLT BACKGROUND AND CARRYOVER FAILURES DUE TO CONTAMINATION. THE FSE INDICATED THAT THE FEW DROPS OF FLUID WHICH APPEARS ON THE TOP EDGE OF THE WBC BATH WHERE DILUENT IS DELIVERED IS A NORMAL OCCURRENCE DURING THE RINSING PROCESS AND DOES NOT IMPACT PATIENT RESULTS. THE FSE DECONTAMINATED THE UNIT AND RESOLVED THE ISSUE OF PLATELETS CARRYOVER ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113770 COULTER® AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1