BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF ANALYZER

    MDR report key: 3103476 · Received May 9, 2013

    Report

    Report Number
    1061932-2013-00755
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED A WORN RED STRIPED TUBING FROM PINCH VALVE VL15. THE FSE INDICATED THAT THE TUBING HAD A HOLE AS IT WAS RUBBING ON THE BOTTOM OF THE SAMPLE SYRINGE ASSEMBLY. THE FSE REPLACED THE TUBING AT VL15 TO RESOLVE THE LEAK. FAILURE MODE IS ATTRIBUTED TO A HOLE IN THE RED STRIPED TUBING FROM VL15. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK ONTO THE COUTERTOP FROM THE RIGHT HAND SIDE OF THE COULTER ACT DIFF ANALYZER. THE CUSTOMER INDICATED THAT APPROXIMATELY 8 OUNCES OF FLUID LEAKED AND PLT (PLATELETS) FAILED ON STARTUP AFTER A SHUTDOWN. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS 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
    202749 COULTER® AC*T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1