BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2 ANALYZER

    MDR report key: 2774906 · Received October 5, 2012

    Report

    Report Number
    1061932-2012-02507
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 13, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS ARE RUN ONCE PER DAY AND WERE RUNNING WITHIN SPECIFICATIONS. CONTROLS WERE NOT RE-RUN AFTER THE EVENT. THE PATIENT SAMPLES WERE COLLECTED USING A FINGER STICK. SAMPLES WERE LESS THAN 1 HOUR OLD. THEY DID NOT APPEAR ABNORMAL. SAMPLES WERE RUN IN OPEN VIAL WHOLE BLOOD MODE. PREVIOUSLY RUN SAMPLES WERE NOT RERUN. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND FOUND A PLUG IN THE DRAIN SYSTEM NOT ALLOWING THE WBC BATH TO DRAIN CAUSING IT TO OVERFLOW. THE FSE CLEARED THE BLOCKAGE IN TUBING CONNECTED TO VL15 TO RESOLVE THIS ISSUE. THE FSE ALSO REPLACED THE HEMOGLOBIN (HGB) LAMP WHILE ON-SITE. BECKMAN COULTER DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN SAMPLES AND SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF THE INSTRUMENT RESULTS. ALL FLAGGING OPTIONS INCLUDE REFERENCE RANGES (H/L), CODES, AND FLAGS. BECKMAN COULTER RECOMMENDS AVOIDING THE USE OF SINGLE MESSAGES OR OUTPUTS TO SUMMARIZE SPECIMEN RESULTS OR PATIENT CONDITIONS. THE CAUSE OF THIS EVENT WAS THE PLUG IN THE BATH DRAIN PATH. PER FSE, THE PLUG CAUSED THE BATH OVERFLOW AND AFFECTED THE RESULTS. HOWEVER, THE ROOT CAUSE OF WHAT CAUSED THE PLUG WAS NOT DETERMINED; MOST LIKELY A CLOT OR CELLULAR DEBRIS. IT IS NOT CONSIDER AS AN INSTRUMENT MALFUNCTION SINCE NO PARTS WERE REPLACED THAT AFFECT BATH DRAIN. PATIENT INFORMATION PROVIDED IS FOR PATIENT 1. PATIENT INFORMATION FOR PATIENT 2 AND PATIENT 3 IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THEIR COULTER ACT DIFF 2 ANALYZER GAVE INCOMPLETE WHITE BLOOD CELL (WBC) COMPUTATION FLAGGED RESULTS ON A FINGER STICK PATIENT SAMPLE AND NOTICED AN ESTIMATED 14ML OF CLEAR FLUID LEAKING FROM UNDERNEATH THE INSTRUMENT. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND SPILLED ONTO THE COUNTER. THE CUSTOMER WAS WEARING GLOVES AND A GOWN. THERE WAS NO EXPOSURE TO SKIN, OPEN WOUNDS, OR MUCOUS MEMBRANES. THE MSDS IS ON-SITE BUT WAS NOT REVIEWED. THEY DO HAVE A RISK MANAGEMENT PLAN. THE CUSTOMER PROVIDED PATIENT SUMMARY PRINTOUTS TO SHOW THREE PATIENTS RUN IN MANUAL MODE ON THEIR ACT DIFF2 DID NOT MATCH RESULTS FROM THE RESPECTIVE SPECIMENS RUN ON THEIR LH500 INSTRUMENT WHICH WERE CONSIDERED CORRECT. SAMPLE OF PATIENT 1 WAS RUN THREE TIMES ON THE ACT DIFF2 INSTRUMENT GIVING HIGH WBC AND LOW RED BLOOD CELL (RBC), HEMOGLOBIN (HGB), AND PLATELET (PLT) RESULTS WITH INSTRUMENT GENERATED WBC FLAGS COMPARED TO THE LH500 RESULTS. SAMPLE OF PATIENT 2 WAS RUN TWICE ON THE ACT DIFF2 INSTRUMENT GENERATING HIGH WBC, MEAN CORPUSCULAR VOLUME (MCV) AND LOW RBC, HGB, AND PLT RESULTS WITH INSTRUMENT GENERATED WBC FLAGS COMPARED TO THE LH500 RESULTS. SAMPLE OF PATIENT 3 WAS TESTED ONCE ON THE ACT DIFF2 INSTRUMENT WHICH GAVE HIGH WBC, RBC, AND PLATELET (PLT) AND LOW MCV RESULTS WITH INSTRUMENT GENERATED WBC FLAG COMPARED TO THE LH500 RESULTS. IN EACH CASE, INSTRUMENT FLAGS AND OR NON-NUMERIC RESULTS WERE GENERATED TO ALERT THE OPERATOR TO REVIEW THE RESULTS. THE RESULTS WERE BELIEVED TO BE ERRONEOUS BECAUSE THEY WERE VERY HIGH AND DID NOT CORRELATE WITH THEIR LH500 ANALYZER RESULTS. PATIENTS' DATA IS PROVIDED IN THE ATTACHMENT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. AC T DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR