BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD1800 ANALYZER

    MDR report key: 1023656 · Received April 1, 2008

    Report

    Report Number
    2919069-2008-00479
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ABBOTT DIAGNOSTIC DIVISION/CELL DYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER REPORTED SEEING LOW HEMOGLOBIN (HCB) ON CELL-DYN 1800 ANALYZER, WHEN COMPARED TO ANOTHER CD1800 IN THE CHEMISTRY LAB. THE CUSTOMER ALSO NOTED THE HIGH LEVEL OF CONTROL WERE OUT OF RANGE FOR HGB SINCE THE DAY BEFORE. THE CUSTOMER PERFORMED HGB FLOW CELL CLEANING AND REPLACED THE DILUENT AND LYSE REAGENTS WITHOUT RESOLUTION. THE CUSTOMER ALSO COMPARED 2 VENOUS SAMPLES, FINDING THE HGB WAS RECOVERING HIGHER ON THE COMPLAINT INSTRUMENT. THE ACCOUNT HAD HAD FIELD SERVICE IN THE PREVIOUS WEEK FOR A CONTROL ISSUE. ALL REAGENT LINES WERE FREE OF CRIMPS/OBSTRUCTIONS, ALL SYRINGES FREE OF BUBBLES/LEAKS. CALIBRATION WAS COMPLETED JANUARY 8 (LAB TEMPERATURE AT 77 DEGREES). ALL MAINTENANCE WAS UP TO DATE AND CONTROLS WERE RUN AS PER INSERT INSTRUCTIONS. THE CUSTOMER REPORTED CONTROLS WERE OUT OF RANGE (OOR) HIGH FOR WBC (HIGH CONTROL) AND THE HGB WAS RUNNING HIGH FOR LOW AND NORMAL CONTROL. THE CUSTOMER CHECKED AND THERE WERE NO CLOTS ON ANY OF THE SUSPICIOUS RESULTS. THE CUSTOMER CLEANED THE APERTURE PLATE AND PERFORMED SUPPLEMENTARY APERTURE CLEANING. FIVE PT SAMPLES WERE RUN ON BOTH INSTRUMENTS AFTER APERTURE CLEANING AND SUPPLEMENTAL APERTURE CLEANING. THE RESULTS MATCHED. THE FSR RUN A PRECISION AND AUTOCAL. DATA SHOWED HGB CV% = 1.0 (RANGE =< 1.2 OPERATOR MANUAL P. 4-15). IN 2008, THE CUSTOMER REPORTED THE HGB WAS OOR HIGH ON THE HIGH CONTROL. THE CTA REQUESTED THE CUSTOMER PRIME AN AUTOCAL AND RERUN CONTROLS. THE HIGH CONTROL RECOVERED IN RANGE. THE CUSTOMER WAS TO MONITOR. ON FOUR DAYS LATER, THE CUSTOMER REPORTED ALL CONTROLS WERE IN RANGE AND NO FURTHER SUSPICIOUS RESULTS HAD BEEN GENERATED SINCE LAST CONTACT. THE CUSTOMER WAS SATISFIED THE ISSUE WAS RESOLVED AND NO FURTHER F/U REQUIRED. THE ISSUE HAD BEEN RESOLVED BY APERTURE PLATE AND SUPPLEMENTAL APERTURE PLATE CLEANING. THE CELL-DYN SYSTEM 1800 OPERATOR'S MANUAL, 07H80-01, REV D: SECTION 9 STATES IN THE OVERVIEW OF MAINTENANCE AND SERVICE THAT: OVERDUE MAINTENANCE IS USUALLY INDICATED BY AN IMPRECISION OF ONE OR MORE OF THE DIRECTLY-MEASURED PARAMETERS. THIS IMPRECISION IS DUE TO CARRYOVER OR DILUTION/SAMPLING INCONSISTENCIES. IF THIS OCCUR ON MORE THAN A RANDOM BASIS, PERFORM THE APPROPRIATE MAINTENANCE MORE FREQUENTLY THAN INDICATED (PAGE 9-1). APERTURE PLATE AND SUPPLEMENTAL APERTURE PLATE CLEANING ARE AS NEEDED MAINTENANCE ACTIVITIES. (PAGES 9-43 TO 9-46). FLOW CELL CLEANING (9-35 TO 9-38 IS ALSO AS A NEEDED MAINTENANCE. SECTION 10: APERTURE PLACE CLEANING AND SUPPLEMENTAL APERTURE PLATE CLEANING IS THE ACTION RECOMMENDED WHERE ISSUES WITH DEBRIS ARE SUSPECTED E.G. UNACCEPTABLE BACKGROUND, HIGH MCV WITH LOW MCHC VALUES. FLOW CELL CLEANING IS REFERENCED ON PAGES 10-35 AND 10-36 AS A TROUBLESHOOTING ACTIVITY FOR ISSUES WITH INACCURATE OR IMPRECISE PT RESULTS OR HGB READINGS. TRENDING A REVIEW OF COMPLAINT REPORTS, FOR THE PERIOD JUNE 2007 THROUGH JANUARY 2008, DID NOT INDICATE ANY ADVERSE TREND WITH THE CELL-DYN 1800, LIST BASE 07H77-01, FOR THE COMPLAINT ISSUE. THERE WAS NO SYSTEMIC ISSUE. LABELING: THE EVENT IS ADDRESSED IN THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL, 07H80-01, REV D SECTION 4: PERFORMANCE CHARACTERISTICS AND SPECIFICATIONS: PERFORMANCE SPECIFICATION; PRECISION: 4-15 SECTION 9: SERVICE AND MAINTENANCE: AS REQUIRED MAINTENANCE: CLEANING THE HGB (HEMOGLOBIN) FLOW CELL: 9-36 TO 9-38. APERTURE PLATE/SUPPLEMENTAL APERTURE PLATE CLEANING 9-43 TO 9-46 SECTION 10: TROUBLESHOOTING AND DIAGNOSTICS INDEX OF ERROR MESSAGES AND CONDITIONS; DATA PROBLEMS 10-30, 10-35, 10-36. CONCLUSION: THE DEVICE INVOLVED IN THE EVENT WAS EVALUATED AND FOUND TO BE OUT OF SPECIFICATION FOR HEMOGLOBIN CONTROLS OUT OF RANGE. THE ISSUE WAS RESOLVED BY CLEANING THE ANALYZER AND PERFORMING VERIFICATION TESTING. THERE WAS NO IMPACT TO PT MGMT REPORTED. THIS IS THE FINAL REPORT. END OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THEY NOTED DISCREPANT HEMATOLOGY RESULTS FOR ONE PT WITH SAMPLES RUN ON THE CELL-DYN 1800 ANALYZER AND RESULTS OBTAINED FROM ANOTHER CELL-DYN 1800 ANALYZER AT THE SAME FACILITY. PARAMETER: WBC, 1ST RESULT: 2.6 K/UL, 2ND RESULT: 3.9 K/UL. PARAMETER: RBC, 1ST RESULT: 6.25 M/UL, 2ND RESULT: 4.03 K/UL. PARAMETER: HGB, 1ST RESULT: 20.4 G/DL, 2ND RESULT: 12.2 G/DL. PARAMETER: HCT, 1ST RESULT: 59.9%, 2ND RESULT: 38.8%. PARAMETER: PLT, 1ST RESULT: 102 K/UL, 2ND RESULT: 265 K/UL. THERE WAS NO ADVERSE IMPACT TO PT MANAGEMENT REPORTED, DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTIC DIVISION/CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT NO. 61380I2| CD18 CNF HGB LYSE REAGENT LIST NO. 7H84-02