BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF ANALYZER

    MDR report key: 3230633 · Received July 16, 2013

    Report

    Report Number
    1061932-2013-01397
    Event Type
    Malfunction
    Date Received
    July 16, 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
    NY, 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 DISCOVERED A DISCONNECTED WBC (WHITE BLOOD CELL) BATH DRAIN TUBING AND PROCEEDED TO REATTACH THE TUBING TO RESOLVE THE LEAK. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND NO FURTHER ISSUES WERE NOTED. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A DISCONNECTED WBC BATH DRAIN TUBING. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BLUE COLORED FLUID LEAKED FROM THE COULTER AC*T DIFF ANALYZER AND ONTO THE COUNTER WHILE PERFORMING A STARTUP CYCLE. THE CUSTOMER INDICATED THAT THE VOLUME OF FLUID LEAKED WAS APPROXIMATELY THE SIZE OF THE BOTTOM OF THE INSTRUMENT SURFACE AREA. THE CUSTOMER WAS WEARING GLOVES AT THE TIME OF THE EVENT. 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
    328096 COULTER® AC*T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1