BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD 3000 CS

    MDR report key: 1036331 · Received April 29, 2008

    Report

    Report Number
    2919069-2008-00515
    Event Type
    Malfunction
    Date Received
    April 29, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 17, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    GKZ
    PMA / PMN Number
    K980614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE CUSTOMER STATES THAT THEY ARE HAVING AN ISSUE WITH HEMOGLOBIN (HGB) RECOVERY USING A CELL-DYN 3000CS ANALYZER. APPROXIMATELY TEN PT SAMPLES WERE AFFECTED, HOWEVER, THE CUSTOMER PROVIDED ONLY ONE PT DATA EXAMPLE. THE CUSTOMER HAD CLEANED THE HGB FLOWCELL, EXERCISED VALVE 14 AND CHANGED THE PINCH TUBING FOR VALVES 14 AND 15 WITHOUT RESOLVING THE HGB ISSUE. QC (R&D CONTROL) WAS IN RANGE. A CUSTOMER TECHNICAL ADVOCATE (CTA) WALKED CUSTOMER THROUGH EXERCISES VALVES 13, 15, 41, 42, 44. CUSTOMER ALSO REPLACED PINCH TUBING IN VALVES 13, 41, 42, 44--ALL VALVES APPEARED TO OPERATE PROPERLY. THE HGB LYSE AND DILUENT SYRINGE WERE PROPERLY SEATED, NO BUBBLES WERE SEEN AND THE SYRINGE MOVEMENT WAS SMOOTH. HOWEVER, THE CUSTOMER OBSERVED THAT THERE WAS TOO MUCH REAGENT IN THE HGB MIXING CHAMBER AFTER CYCLING, WHICH DILUTED THE NEXT SAMPLE, CAUSING LOW HGB READINGS. FIELD SERVICE WAS DISPATCHED. FSR VISITED ON 4/17/2008 AND REPLACED, AS HARD FAILURE, FIVE WORN SOLENOID VALVES (V34, V35, V36, V37, V38). VERIFICATION PROCEDURE 3 (VP3) FOR SOLENOID OPERATION PASSED. VP8 (HGB FLOWCELL CLEANING AND ADJUSTMENT) WAS PERFORMED AND PASSED. THE CELL-DYN SYSTEM 3000 OPERATOR'S MANUAL, 92430-01, REV H: THE TROUBLESHOOTING GUIDE (SECTION 10 PAGES 10-25 TO 10-26) STATES THAT IN THE PROBLEM IDENTIFICATION STEP THE CUSTOMER SHOULD BE OBSERVING WHAT IS RIGHT AND WHAT IS WRONG TO FURTHER ISOLATE THE CATEGORY OF PROBLEM (HARDWARE, SOFTWARE OR MEASUREMENT). SECTION 3, SAMPLE ANALYSIS CYCLE OVERVIEW OUTLINES THE PROCESS OF ANALYSIS (PAGES 3-2 TO 3-4). PRECISE VOLUMES OF BLOOD ARE DILUTED WITH SPECIFIC VOLUMES OF REAGENT ACCORDING TO THE TYPE OF ANALYSIS BEING DONE. THE HGB DETERMINATION IS MADE FROM 1.2 UL OF BLOOD ADDED TO 1.5ML OF DILUENT AND 1.5ML HEMOGLOBIN LYSE REAGENT, WHICH IS MIXED BY BUBBLING ACTION IN THE HGB MIXING CHAMBER. THE MIXING CHAMBER AND FLOW CELLS ARE RINSED AFTER EACH CYCLE. THE VOLUME OF LIQUID IN THE MIXING CHAMBER SHOULD BE CONSISTENT CYCLE TO CYCLE. THE CUSTOMER OBSERVED WHILE CHECKING THE MOVEMENT OF SYRINGES AND VALVES, THAT THERE WAS TOO MUCH REAGENT IN THE MIXING CHAMBER, WHICH INDICATED A MEASUREMENT PROBLEM FOR HGB ANALYSIS AT MIXING CHAMBER AND A POSSIBLE HARDWARE ISSUE RELATED TO THE FILL/DRAIN OF THE MIXING CHAMBER. TRENDING ANALYSIS: A REVIEW OF THE COMPLAINT REPORTS, FOR THE PERIOD AUGUST 2007 THROUGH MARCH 2008, DID NOT INDICATE ANY ADVERSE TREND WITH THE CELL-DYN 3000, LIST BASE 91250-01, (WHICH INCLUDED 91323-03) FOR ISSUES WITH ERRATIC/LOW HGB RESULTS. THERE WAS NO SYSTEMIC ISSUE. LABELING: THE EVENT IS ADDRESSED IN THE CELL-DYN 3000 SYSTEM OPERATOR'S MANUAL, 92420-01, REV H SECTION 3: PRINCIPLES OF OPERATION: SAMPLE ANALYSIS CYCLE OVERVIEW; 3-2 TO 3-4 SECTION 10: TROUBLESHOOTING AND DIAGNOSTICS: TROUBLESHOOTING GUIDE; 10-25 TO 10-26. CONCLUSION: THE DEVICE INVOLVED IN THE EVENT WAS EVALUATED. SERVICE REPLACED SOLENOID VALVES THAT WERE INTERMITTENTLY FAILING TO RESOLVE THE ISSUE. NO IMPACT TO PT MANAGEMENT WAS REPORTED DUE TO THIS ISSUE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT HEMOGLOBIN RESULTS ON PT SAMPLES HAVE BEEN ERRATIC AND LOW WHEN GENERATED USING A CELL-DYN 3000 CS ANALYZER. AN EXAMPLE FOR ONE PT WAS PROVIDED; HGB=5 G/DL COMPARED TO A PREVIOUSLY OBTAINED RESULT OF 15 G/DL. INCORRECT RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD 3000 CS AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LOT NO. 59150I2| CD HEMOGLOBIN LYSE REAGENT LIST NO. 99411-01