BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 5983157 · Received September 28, 2016

    Report

    Report Number
    2919069-2016-02144
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    Date of Event
    September 7, 2016
    Report Date
    April 22, 2017
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740017170
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED; THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED AND THE EVALUATION CODES WERE CORRECTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE. A REVIEW OF THE PATIENT RESULTS FOUND THAT ANY CORRELATION BETWEEN THE INITIAL RESULTS AND THE RESULTS FROM THE NEXT DAY (TESTED ON THE SAME SAMPLE) COULD NOT BE PERFORMED. THE INITIAL RESULTS ALERTED THE OPERATOR TO PERFORM VERIFICATION BECAUSE ALL THE RESULTS WERE MARKED "SUSPECT". ALL WBC PARAMETER RESULTS ON THE FOLLOWING DAY WERE INVALIDATED WITH AN " * " (ASTERISK); THEREFORE, THESE RESULTS SHOULD NOT BE USED OR REPORTED OUT OF THE LAB AND SHOULD NOT BE USED FOR CORRELATION WITH THE INITIAL RUN. BOTH INITIAL AND REPEAT RESULTS REQUIRED A SMEAR REVIEW VERIFICATION. THE DELL_DYN RUBY OPERATORS MANUAL CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT MALFUNCTION OCCURRED. THE CELL-DYN RUBY ANALYZER PERFORMED AS DESIGNED WHEN PRESENTED WITH A PATHOLOGY SAMPLE AND PROVIDED FLAGGING ALERTS FOR THE OPERATOR TO PERFORM FURTHER VERIFICATION BEFORE REPORTING OUT OF THE LAB. THE ISSUE WAS ISOLATED TO A SINGLE SAMPLE INVOLVING A SAMPLE WITH INTERFERING SUBSTANCE(S) AND CONDITIONS WHICH AFFECTED SAMPLE PROCESSING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT ONE PATIENT SAMPLE ((B)(6)) GENERATED AN INITIAL WBC COUNT OF 21.8 K/UL ON A CELL-DYN RUBY ANALYZER. RESULTS WERE FLAGGED WITH IG/BAND AND VAR LYM AND RESULTS WERE REPORTED FROM THE LAB. THE CUSTOMER DECIDED TO RETEST THE SAMPLE THE FOLLOWING DAY SINCE THE WBC COUNT WAS ELEVATED AND GENERATED A WBC COUNT OF 23.0 K/UL WITH FLAGGED RESULTS OF FWBC/NWBC, VAR LYM AND DFLT (NLMEM). THIS PROMPTED A RETEST OF THE SAMPLE IN THE CBC+NOC MODE OF OPERATION, WHICH GENERATED A FINAL WBC COUNT OF 106 K/UL. THIS ELEVATED RESULT WAS VERIFIED BY A MANUAL SLIDE REVIEW AND BY THE PATIENT'S CURRENT CLINICAL CONDITION. THE PATIENT IS DIAGNOSED WITH ACUTE LYMPHOID LEUKEMIA (ALL). THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633823 CELL-DYN RUBY ANALYZER AUTOMATED HEMATOLOGY ANALYZER, GKZ ABBOTT DIAGNOSTICS DIVISION 00380740017170

    Patients

    Seq Age Sex Outcome Treatment
    1