BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF ANALYZER

    MDR report key: 3141201 · Received June 3, 2013

    Report

    Report Number
    1061932-2013-00944
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER CTS (CUSTOMER TECHNICAL SPECIALIST) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE AND ADVISED THE CUSTOMER TO CLEAN THE PROBE WIPE RINSE BLOCK FITTING BY BLEACHING AND FLUSHING THROUGH TUBING #5 TO REMOVE ANY POSSIBLE OBSTRUCTION. THE CUSTOMER RECONNECTED THE TUBING TO THE PROBE WIPE AND RAN CONTROLS AND NO FURTHER LEAKS WERE OBSERVED. FAILURE MODE IS ATTRIBUTED TO A POSSIBLE OBSTRUCTION IN THE PROBE WIPE THROUGH TUBING #5. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF LESS THAN 1 ML FROM THE PROBE OF THE COULTER AC*T DIFF ANALYZER FOLLOWING SAMPLE ASPIRATION AND AFTER THE SAMPLE TUBE HAD BEEN MOVED AWAY FROM THE PROBE. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. 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 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
    243088 COULTER® AC*T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1