BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2 ANALYZER

    MDR report key: 2973195 · Received February 21, 2013

    Report

    Report Number
    1061932-2013-00209
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE TROUBLESHOOTING WITH BEC CTS (CUSTOMER TECHNICAL SUPPORT), THE CUSTOMER ALSO REPORTED THAT THE WBC AND RBC BATHS AND THE VACUUM ISOLATOR CHAMBER WERE NOT DRAINING DUE TO A CLOGGED FILTER SO THEY REPLACED WASTE FILTER AND TURNED OFF THE INSTRUMENT. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND OBSERVED THE ERRATIC RESULTS. FSE REPLACED THE DILUENT SYRINGE WHEN HE FOUND THE RUBBER SYRINGE BOOT ON THE DILUENT SYRINGE WAS NOT CUT TO ALLOW THE SYRINGE TO VENT PROPERLY. MIXING CHECK VALVES, BLUE DILUENT FILTERS AND THE VACUUM ISOLATION CHAMBER WERE ALSO CHANGED AS A PREVENTATIVE MEASURE. VERIFICATION WAS PERFORMED AND ALL PARAMETERS PASSED WITHIN SPECIFICATIONS. PREVIOUSLY RUN SAMPLES WERE RUN BACK TO THE LAST ACCEPTABLE QC RUN AND CONTROLS PASSED WITH NO FLAGGED RESULTS. THE CAUSE OF THE LEAK WAS A CLOGGED WASTE FILTER AND THE CAUSE FOR THE ERRONEOUS RESULT WAS THE RUBBER SYRINGE BOOT NOT VENTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING A CLEAR LEAK FROM THEIR COULTER ACT DIFF 2 ANALYZER. THE VOLUME OF THE LEAK WAS 2OZ. THE CUSTOMER ALSO STATED THAT THERE WAS ONE SPECIFIC SAMPLE THAT HAD ERRONEOUS RESULTS ON ALL COUNTED PARAMETERS AND HEMOGLOBIN (HGB) AT THE TIME OF THE LEAK. DATA SUBMITTED FOR BEC REVIEW INDICATED THAT THERE WERE INSTRUMENT GENERATED RESULTS FOR ALL 3 RUNS WITH INSTRUMENT GENERATED FLAGS WHICH ALERTED THE OPERATOR TO REVIEW THE RESULTS FURTHER. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY HOWEVER THERE WAS NO IMPACT ON OR AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, LAB COAT AND FACE PROTECTION AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75607 COULTER® ACT DIFF 2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER ACT DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1