BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD RUBY

    MDR report key: 975859 · Received January 8, 2008

    Report

    Report Number
    2919069-2008-00008
    Event Type
    Other
    Date Received
    January 8, 2008
    Date of Event
    November 1, 2007
    Report Date
    December 18, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE CUSTOMER REPORTED DISCREPANT RESULT FOR WBC ON ONE PT. THE INSTRUMENT IN USE WAS A CELL-DYN RUBY ANALYZER. THE FIRST RUN GAVE WBC = 52,000/UL WITH FLAGGING OF NRBC/RRBC, VAR LYM, WBC. THE SECOND RUN (USED AS CONTROL ON THE 2ND DAY) GAVE A WBC = 61,200 /UL WITH FLAGGING OF NRBC/RRBC, VAR LYM, WBC. THE CUSTOMER STATES THE PT WAS UNNECESSARILY HOSPITALIZED BECAUSE THE WBC COUNT FROM ANOTHER LAB RECOVERED NORMAL RESULTS. PER THE OPERATING PROCEDURES, THE NRBC FLAG REQUIRES DOING SUPPLEMENTARY TESTS BEFORE INTERPRETING THE RESULTS. THE INITIAL TEST RESULTS, THEREFORE, SHOULD NOT HAVE BEEN ISSUED FROM THE LABORATORY. FOLLOW-UP IN LATE 2007 REPORTED THAT THE ISSUE HAD BEEN RESOLVED BY CUSTOMER TRAINING ON FLAGGING (ALARMS). THE CELL-DYN RUBY SYSTEM OPERATOR'S MANUAL PROVIDES INFO ON FLAGGING. FOR THE DESCRIPTOR/FLAG WBC, NRBC/RRBC THE CAUSE IS CELLULAR DEBRIS IS HIGH WITH DECLINING WOC KINETIC RATE. THE SUGGESTED ACTION IS TO REPEAT SAMPLE IN CBC+ RRBC MODE AND IF FLAGS AGAIN SHOW, TO REVIEW A SMEAR TO VERIFY PRESENCE OF NRBC AND LYMPHOCYTE COUNT. CONFIRM WBC BY ALTERNATE METHOD. THE VAR LYM FLAG ALSO HAS A SUGGESTED ACTION OF REVIEWING A SMEAR AND FOLLOWING THE LABORATORY REVIEW PROTOCOL. LABELING: A REVIEW OF COMPLAINT REPORTS, FOR THE PERIOD MARCH 2007 THROUGH NOVEMBER 2007, DID NOT INDICATE ANY ADVERSE TREND FOR CELL-DYN RUBY, LIST BASE 08H67-01 FOR ISSUES WITH EVALUATION OF FLAGGED SAMPLES. TRENDING: THE EVENT IS ADDRESSED IN THE CELL-DYN RUBY SYSTEM OPERATOR'S MANUAL. PRINCIPLES OF OPERATION: OPERATIONAL MESSAGES AND DATA FLAGGING; PT SPECIMEN TYPE + CBC TEST SELECTION. CONCLUSION: THE CELL-DYN RUBY ANALYZER WAS EVALUATED AND THE INVESTIGATION CONCLUDED THAT USER ERROR CONTRIBUTED TO THE EVENT. THE CUSTOMER FAILED TO FOLLOW INSTRUCTION IN THE OPERATOR'S MANUAL FOR FLAGGED RESULTS, WHICH RESULTED IN REPORTING A RESULT THAT REQUIRED FURTHER EVAL PRIOR TO INTERPRETATION. TRAINING THE CUSTOMER RESOLVED THE ISSUE. A PT WAS HOSPITALIZED AS A RESULT OF THE EVENT WITH NO REPORT OF FURTHER IMPACT TO PT MANAGEMENT OTHER THAN BEING RETESTED AT ANOTHER FACILITY. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT RESULTS FOR WBC ON ONE PT. THE INSTRUMENT IN USE WAS A CELL-DYN RUBY ANALYZER. THE FIRST RUN GAVE WBC = 52,000/UL WITH FLAGGING OF NRBC/RRBC, VAR LYM, WBC. THE SECOND RUN (USED AS CONTROL ON THE 2ND DAY) GAVE A WBC=61,200/UL WITH FLAGGING OF NRBC/RRBC, VAR LYM, WBC. THE PT WAS HOSPITALIZED BASED ON THE WBC COUNT REPORTED. TESTING PERFORMED AT ANOTHER LAB YIELDED A WBC RESULT IN THE NORMAL RANGE. THERE WAS NO FURTHER IMPACT TO PT MANAGEMENT REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD RUBY AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization