BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF ANALYZER

    MDR report key: 2951050 · Received February 8, 2013

    Report

    Report Number
    1061932-2013-00169
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE FOUND THE PROBE WIPE BLOCK WAS DRIPPING UPON ARRIVAL. THE FSE REPLACED VALVE VL8 TO RESOLVE THE LEAK. WHILE AT THE CUSTOMER SITE, THE FSE ALSO OBSERVED THE RED BLOOD COUNT (RBC) ON CONTROLS WAS BELOW TARGET VALUE ON ALL 3 LEVELS, AND OUT LOW ON THE HIGH LEVEL ONLY. THE FSE ADJUSTED THE RBC CALIBRATION FACTOR TO BRING THE MEAN RECOVERY TO ASSAY TARGET VALUE. FAILURE MODE OF THIS EVENT WAS ATTRIBUTED TO VALVE VL8. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT ABOUT 2CC OF ANIMAL BLOOD AND DILUENT DRIPPED FROM THE PROBE ON THEIR COULTER ACT DIFF ANALYZER AFTER ASPIRATION AND POOLED ONTO THE COUNTER TOP. THE EVENT OCCURRED AT THE VETERINARY FACILITY. THE CUSTOMER STATED THE ANALYZER ASPIRATED THE BLOOD BUT WAS SPITTING IT BACK OUT. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT DID NOT GENERATE ANY RESULTS OR ERRORS. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF A LAB COAT AND GLOVES AT THE TIME OF THE EVENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53876 COULTER® ACT DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1