BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 1251184 · Received December 5, 2008

    Report

    Report Number
    2919069-2008-00808
    Event Type
    Malfunction
    Date Received
    December 5, 2008
    Date of Event
    May 5, 2008
    Report Date
    October 27, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Removal / Correction Number
    Z-1064-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS, (B)(4) (OTHER), LABELING INFORMATION INADEQUATE/INCORRECT. AN INVESTIGATION WAS CONDUCTED TO SOLVE THE ISSUE OF THE OCCASIONAL HIGH PLATELETS (PLT) BACKGROUND COUNTS REPORTED WHILE EXECUTING QUALITY CONTROL (QC) RUNS. DURING SUBSEQUENT VALIDATION TESTING, ELEVATED RED BLOOD CELLS (RBC) BACKGROUND WAS ALSO OBSERVED. THE QC CARRYOVER COUNTING FLOW SEQUENCE IS THE SAME FOR CBC TEST SELECTION WHICH IS THE MOST FREQUENT TEST USED BY THE CUSTOMER. THE INCREASED TREND OF PLT CARRYOVER FAILURES DURING A REVIEW OF INSTRUMENT INVESTIGATION REPORTS FOR THE MONTHS OF (B)(6) AND (B)(6) OF 2008 WAS ALSO OBSERVED. THE INVESTIGATION FOUND A DESIGN CHANGE OCCURRED RELATIVE TO A PREDECESSOR INSTRUMENT THAT IMPACTED CARRYOVER. THIS DESIGN ERROR ALLOWS BUBBLES THAT ARE GENERATED FROM BUBBLE MIXING (AGITATION BY BURSTS OF AIR PRESSURE) OF THE SPECIMEN SOLUTION TO EXTEND INTO THE UPPER SURFACE AREAS OF THE RBC/PLT MIXING CHAMBER THAT WERE NOT INTENDED TO BE RINSED BY DESIGN. THIS OCCASIONALLY CAUSES PLT % CARRYOVER PERFORMANCE TO EXCEED SPECIFICATIONS. THE RBC % CARRYOVER IS IMPACTED AS WELL FOR THE SAME REASON. IT WAS DETERMINED THAT THE CARRYOVER PERFORMANCE FOR PLT IS LESS THAN OR EQUAL TO 1.7% AND FOR RBC IS LESS THAN OR EQUAL TO 1.2%. CARRYOVER PARAMETERS WERE NOT CHALLENGED UNDER THE CBC TEST SELECTION DURING VALIDATION AND VERIFICATION AND CLINICAL TESTING PRIOR TO PRODUCT LAUNCH. A CELL-DYN RUBY PRODUCT DEFICIENCY WAS ESTABLISHED FOR THE PLT AND RBC % CARRYOVER PARAMETERS THAT LED TO FIELD ACTION (B)(4). THE COMMUNICATION TO CUSTOMERS INCLUDED MODIFIED SPECIFICATIONS FOR CARRYOVER TO THE PLT AND RBC PARAMETERS. THE PLT AND RBC % CARRYOVER IS LESS OR EQUAL TO 1.0% IN THE CELL-DYN RUBY SYSTEM OPERATOR'S MANUAL. IT WAS RECOMMENDED TO UPDATE THE CARRYOVER LABELING CLAIMS FOR PLT TO 1.7% AND FOR RBC% TO 1.2%. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    AN IN-HOUSE SOFTWARE ENGINEER REPORTED THAT THE CELL-DYN RUBY ANALYZER HAS SHOWN HIGH BACKGROUND COUNTS INTERMITTENTLY ON PLATELET PARAMETER AND OCCASIONALLY ON THE RED BLOOD CELLS. NOC FLOW ERROR WAS ALSO DISPLAYED UNDER THE BASOPHILES RESULT IN THE RUN VIEW. IT FLAGS INVALID NUMERICAL RESULTS FOR WHITE BLOOD CELLS AND DIFFERENTIAL. THIS ISSUE OCCURRED AFTER RUNNING HIGH LEVEL OF CELL-DYN 29 PLUS CONTROL, LOT # 80989. NO IMPACT TO PATIENT MANAGEMENT WAS 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 CELL-DYN 29 PLUS QUALITY CONTROL