BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 1355914 · Received April 7, 2009

    Report

    Report Number
    2919069-2009-00114
    Event Type
    Malfunction
    Date Received
    April 7, 2009
    Date of Event
    March 6, 2009
    Report Date
    March 10, 2009
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DATA WHICH WAS GENERATED WAS PERFORMED. ALL RESULTS FROM THE CBC TEST SELECTION HAD RBC MORPHOLOGY FLAGGING. THE PLATELET (PLT) RESULTS FROM THE CBC+RRBC TEST SELECTION WERE HIGHER WITH NO MPV RESULT (MPV>>>>). ALL PLT RESULTS FROM CBC OR CBC+RRBC MODES HAD DISPERTIONAL DATA ALERTS (UNDERLINED RESULTS). THE CELL-DYN RUBY SYSTEM OPERATOR'S MANUAL, LIST NUMBER 08H56-01, REVISION D, SECTION 3: PRINCIPLES OF OPERATION, PAGE 3-35, PROVIDES THE SUGGESTION TO REVIEW A STAINED SMEAR FOR ABNORMAL RBC OR PLT MORPHOLOGY WHEN RBC MORPH FLAGGING IS PRESENT. PAGE 3-36 OF THE OPERATOR'S MANUAL, PROVIDES AN EXPLANATION OF THE CAUSE AND SUGGESTED ACTION WHEN THERE IS NO MPV RESULT. IN THIS CASE, THE CAUSE IS THE PLT HAS AN ABNORMAL DISTRIBUTION AND THE OPERATOR NEEDS TO REVIEW THE SMEAR FOR ABNORMAL PLT MORPHOLOGY OR PLATELET AGGREGATES AND VERIFY THE PLT COUNT. SECTION 2: INSTALLATION PROCEDURES AND SPECIAL REQUIREMENTS, PAGE 2-12 STATES "A RESULT THAT FALLS OUTSIDE A LABORATORY ACTION LIMIT CAN ALSO INDICATE THE NEED FOR THE OPERATOR TO FOLLOW A LABORATORY PROTOCOL, SUCH AS REPEATING THE SPECIMEN, NOTIFYING THE PHYSICIAN OR PERFORMING A SMEAR REVIEW. IN CASES WHERE A CELLULAR ABNORMALITY IS PRESENT THAT ALTERS CELLULAR MORPHOLOGY TO THE POINT THAT THE CELLS DO NOT FIT THE CRITERIA USED BY THE INSTRUMENT TO GENERATE A FLAG, DISPERSIONAL DATA ALERTS MAY BE THE ONLY FLAGS THAT WILL ALERT THE OPERATOR TO A POTENTIALLY ERRONEOUS RESULT." IN ADDITION THE COMPLAINT ANALYSIS AND TRENDING SYSTEM (CATS) WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. BASED ON THE INVESTIGATION NO MALFUNCTION / DEFICIENCY WAS IDENTIFIED. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CELL-DYN RUBY ANALYZER GENERATED AN INITIAL PLATELET RESULT OF 18,900/UL WITH SUSPECT WBC, NRBC/RRBC AND DFLT FLAGS. THE SAMPLE WAS REPEATED IN CBC+RRBC MODE AND A PLATELET OF 28,200/UL WAS GENERATED WITH AN MPV OF >>>>. THE SAMPLE WAS RUN AGAIN IN THE CBC MODE AND THE PLATELET WAS 19,700/UL WITH WBC, NRBC/RRBC AND DFLT FLAGS. THE SAMPLE WAS RUN AGAIN IN CBC+RRBC MODE AND THE PLATELET WAS 32,100/UL WITH AN MPV OF >>>>. THE CUSTOMER REPORTED THE RESULT OF 19,700/UL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1