BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF 2 ANALYZER

    MDR report key: 3230617 · Received July 16, 2013

    Report

    Report Number
    1061932-2013-01399
    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
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS NOT DISPATCHED FOR THIS EVENT. A BECKMAN COULTER CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE. THE CTS INSTRUCTED THE CUSTOMER CONFIRM IF THE BATHS WERE OVERFLOWING AND THE VIC (VACUUM ISOLATOR CHAMBER) WAS EMPTY. THE CTS THEN ADVISED THE CUSTOMER TO MOVE THE WASTE LINE TUBE IN THE SINK WHICH RESTORED PROPER DRAINING FUNCTION OF THE INSTRUMENT. FAILURE MODE OF THE EVENT IS LIKELY ATTRIBUTED TO A KINKED WASTE LINE TUBE IN THE SINK WHICH PREVENTED PROPER DRAINING OF THE INSTRUMENT. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATHS OF THE COULTER AC*T DIFF 2 ANALYZER OVERFLOWED, AND APPROXIMATELY 2 ML OF FLUID LEAKED ONTO THE COUNTER. 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
    329066 COULTER® AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1