BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF HEMATOLOGY ANALYZER

    MDR report key: 3110266 · Received May 13, 2013

    Report

    Report Number
    1061932-2013-00891
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2013 FOR THIS EVENT. THE FSE INDICATED THAT THE PROBE WAS LEAKING DURING THE PROBE WIPE CYCLE. THE FSE FOUND TUBINGS CONNECTED TO THE RINSE BLOCK PORTS MIS-TUBED. THE VACUUM LINE WAS CONNECTED TO WHERE THE RINSE LINE SHOULD BE AND THE SAME SITUATION WITH THE RINSE LINE CONNECTED TO THE WRONG PORT CAUSING THE LEAK. THE FSE CORRECTED THE TUBES WHICH RESOLVED THE LEAK ISSUE. PER LABELING, BECKMAN COULTER URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE PROBE WAS LEAKING ABOUT 1 ML OF REAGENT MIX AND BLOOD IN THE COULTER AC*T DIFF HEMATOLOGY ANALYZER AFTER ASPIRATION WAS MADE. THE CUSTOMER INDICATED THAT THE SAMPLES WERE REMOVED BEFORE IT DRIPPED INTO THE VIAL SINCE IT WAS BELIEVED THAT THE LEAK WAS AFFECTING THE PATIENT SAMPLES. THE CUSTOMER NOTICED THAT THE HEMOGLOBIN (HGB) RESULTS WERE LOWER THAN NORMAL AND DID NOT REPORT PATIENT SAMPLES. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER INDICATED THAT RE-DRAW OF THE SAMPLE WOULD OCCUR AFTER THE INSTRUMENT WAS SERVICED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AT THE TIME OF OCCURRENCE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. INSTRUMENT PRINTOUTS WERE PROVIDED FOR ONE (1) PATIENT WITH THREE RUNS FROM THE SAME SPECIMEN. ERRATIC WHITE BLOOD COUNT (WBC), RED BLOOD COUNT (RBC), HEMOGLOBIN (HGB), HEMATOCRIT (HCT), PLATELET (PLT), MONOCYTE (MO) %, GRANULOCYTES (GR) % RESULTS WERE OBSERVED ACROSS THE THREE SAMPLE RUNS WITH INSTRUMENT GENERATED FLAGS ON THE MO% AND GR% RESULTS. CORRECT RESULTS WERE NOT PROVIDED FOR COMPARISON. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211542 COULTER AC*T DIFF HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER AC*T DIFF NA

    Patients

    Seq Age Sex Outcome Treatment
    1