BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF 2 ANALYZER

    MDR report key: 3212150 · Received July 8, 2013

    Report

    Report Number
    1061932-2013-01332
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 ADVISED THE CUSTOMER TO FLUSH THE PROBE WIPE VACUUM PATHWAY AND REPLACE THE AIR FILTERS. THE CTS INDICATED THAT THE FILTERS WERE REPLACED SIX MONTHS AGO AND WERE DUE FOR REPLACEMENT. THE CUSTOMER REPORTED THAT THE INSTRUMENT WAS STILL HAVING PROBLEMS AND WAS GENERATING VACUUM ERRORS. A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) CONTACTED THE CUSTOMER VIA TELEPHONE AND ASSISTED THE CUSTOMER WITH TROUBLESHOOTING. THE FSE SUSPECTED THAT THE AIR FILTERS THAT THE CUSTOMER HAD REPLACED MAY HAVE GOTTEN WET IN THE PROCESS AND WERE THE PROBLEM. THE FSE INSTRUCTED THE CUSTOMER TO REPLACE THE AIR FILTERS WITH NEW ONES AND THE CUSTOMER HAS NOT REPORTED A RECURRENCE OF THE EVENT AS OF (B)(6) 2013. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO THE AIR FILTERS REQUIRING REPLACEMENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A DROP OF DILUENT DRIPPED ON TOP OF A SAMPLE TUBE WHILE RUNNING A PATIENT SAMPLE ON THE COULTER AC*T DIFF 2 ANALYZER . THE CUSTOMER INDICATED THAT A FEW DROPS OF FLUID LEAKED AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, GLASSES, AND A LABORATORY COAT AT THE TIME OF THE EVENT 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
    311515 COULTER® AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1