BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF ANALYZER

    MDR report key: 3181144 · Received June 21, 2013

    Report

    Report Number
    1061932-2013-01141
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE. THE CTS INSTRUCTED THE CUSTOMER TO CHANGE THE TUBING AT FITTINGS 4 AND 5 TO THE PROBE WASH AND CHECK FOR CLOTS AT PINCH VALVE VL8. THE CUSTOMER DID NOT OBSERVE ANY CLOTS AND THE ISSUE WAS NOT RESOLVED FOLLOWING TUBING REPLACEMENTS. THE CTS DEFERRED THE SERVICE CALL TO A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) AND THE FSE ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE. THE FSE INSTRUCTED THE CUSTOMER TO REPLACE THE DUAL DILUENT FILTERS ON THE SIDE DOOR OF THE INSTRUMENT AND THERE WERE NO FURTHER LEAKS REPORTED. FAILURE MODE IS ATTRIBUTED TO DUAL DILUENT FILTERS AND THE CUSTOMER REPLACED THE FILTERS TO RESOLVE THE LEAK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF A FEW DROPS OF DILUENT FROM THE PROBE WASH OF THE COULTER AC*T DIFF ANALYZER. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND THAT THERE WERE NO INSTRUMENT-GENERATED ERRORS ASSOCIATED WITH THE REPORTED EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE ASSOCIATED WITH THIS EVENT 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
    281831 COULTER® AC*T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1