BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF ANALYZER

    MDR report key: 3231435 · Received July 17, 2013

    Report

    Report Number
    1061932-2013-01396
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE CONFIRMED ALL THE ISSUES REPORTED BY THE CUSTOMER AND PROCEEDED TO REPLACE THE PROBE WIPE BLOCK TO RESOLVE THE LEAK. THE FSE REMOVED, CLEANED, AND DECONTAMINATED THE DILUENT RESERVOIR, AND PRIMED THE SWEEP FLOW LINE TO RESOLVE THE PLT BACKGROUND ISSUE. RESULTS: FAILURE MODE OF THE LEAK IS ATTRIBUTED TO THE PROBE WIPE BLOCK WHICH NEEDED REPLACEMENT. FAILURE MODE OF THE PLT BACKGROUND FAILURES IS ATTRIBUTED TO THE DILUENT RESERVOIR WHICH NEEDED TO BE CLEANED AND DECONTAMINATED. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THREE DROPS OF FLUID DRIPPED FROM THE PROBE OF THE COULTER AC*T DIFF ANALYZER AFTER A STARTUP CYCLE. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND THAT PLT (PLATELETS) FAILED ON STARTUP. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, AND A LABORATORY COAT AT THE TIME OF THE LEAK AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330452 COULTER® AC*T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1