BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF 2 ANALYZER

    MDR report key: 3203156 · Received July 2, 2013

    Report

    Report Number
    1061932-2013-01325
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED THAT THE VACUUM TRAP WAS FULL, PREVENTING PROPER DRAINAGE OF THE BATHS AND THE VIC (VACUUM ISOLATOR CHAMBER). THE FSE EMPTIED THE VACUUM TRAP TO RESOLVE THE LEAK AND THE VACUUM ERRORS, AND ENSURED THAT THE INSTRUMENT WAS PROPERLY DRAINING. RESULTS: FAILURE MODE OF THE EVENT IS ATTRIBUTED TO A FULL VACUUM TRAP; THE INSTRUMENT OPERATED AS INTENDED BY GENERATING AN ERROR MESSAGE TO ALERT THE CUSTOMER OF AN INSTRUMENT ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATHS OF THE COULTER AC*T DIFF 2 ANALYZER WERE NOT DRAINING AND APPROXIMATELY 5 ML OF FLUID OVERFLOWED ONTO THE COUNTERTOP. THE CUSTOMER INDICATED THAT THE INSTRUMENT GENERATED VACUUM ERRORS AND THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, A LABORATORY COAT, AND GOGGLES AT THE TIME OF THE EVENT 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
    301490 COULTER® AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1