BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3200 SL 110V ANALYZER

    MDR report key: 1222603 · Received November 10, 2008

    Report

    Report Number
    2919069-2008-00772
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K972354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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). DEBRIS IN SOLENOID VALVE, HEMOGLOBIN FLOW CELL AND/OR ASPIRATION PATHWAY. THE CUSTOMER TECHNICAL ADVOCATE (CTA) VERIFIED THAT THE HEMOGLOBIN REFERENCE VALUE AND HEMOGLOBIN OUTPUT WERE WITHIN SPECIFICATION. ALL OF THE REAGENTS WERE CORRECT. THE CTA INSTRUCTED THE CUSTOMER TO CLEAN THE OPTICAL AND HEMOGLOBIN FLOW CELL AND TO RECHECK THE HEMOGLOBIN REFERENCE VALUE/OUTPUT AFTER FLOW CELL CLEANING. THE CTA REVIEWED THE HEMOGLOBIN REFERENCE VALUE AND OUTPUT AND ADJUSTED THE HEMOGLOBIN CURRENT. A SUBSEQUENT PRECISION STUDY YIELDED OUT OF RANGE RESULTS FOR HEMOGLOBIN, RBC AND PLATELETS. THE CTA SUGGESTED FOR THE CUSTOMER TO CLEAN THE OPEN MODE ASPIRATION PATHWAY, SOLENOID VALVE, AND POSSIBLY THE HGB FLOW CELL AGAIN. THE CTA FOLLOWED UP WITH THE CUSTOMER WHO STATED AFTER COMPLETING THE RECOMMENDED TROUBLESHOOTING, PRECISION WAS RUN AND ALL PARAMETERS PASSED THE SPECIFICATIONS. THE CUSTOMER SUBSEQUENTLY CALIBRATED THE INSTRUMENT WITH HEMCAL PLUS CALIBRATOR. POST-CALIBRATION, QC WAS WELL WITHIN RANGE (ONLY OPEN MODE WAS USED). PATIENT RESULTS SHOWED GOOD HEMOGLOBIN/HEMATOCRIT MATCHING AND ALSO COMPARED WELL WITH THE REFERENCE LAB RESULTS (CUSTOMER COULD NOT COMPARE WITH THE CELL-DYN RUBY, AS SERVICE FOR THIS INSTRUMENT WAS REQUIRED). THE CUSTOMER CONSIDERED THE ISSUE ON THE CELL-DYN 3200 INSTRUMENT RESOLVED BY CLEANING AND CALIBRATION. NO FURTHER ASSISTANCE WAS REQUIRED. THE LIKELY CAUSE OF THE ISSUE WAS ATTRIBUTED TO DEBRIS IN THE SOLENOID VALVE, HGB FLOW CELL, AND /OR ASPIRATION PATHWAY AND THE NEED TO ADJUST RELATED CALIBRATOR FACTORS AND HGB CURRENT TO BRING RECOVERIES NEAR TARGET. THE CELL-DYN 3200 SYSTEM OPERATOR'S MANUAL (LIST NUMBER 06H60-01, REVISION N) UNDER SECTION 9, PAGE 9-29, SERVICE AND MAINTENANCE, NONSCHEDULED MAINTENANCE FREQUENCY, INDICATES THAT CLEANING OF THE HGB FLOW CELL SHOULD BE PERFORMED WHEN IT IS SUSPECTED OF CAUSING ELEVATED HGB RESULTS OR HGB IMPRECISION. SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS, PAGES 10-23 THROUGH 10-27, PROVIDES TROUBLESHOOTING INSTRUCTIONS FOR IDENTIFYING, ISOLATING AND CORRECTING DATA RELATED ISSUES. SECTION 6, CALIBRATION PROCEDURES, GENERAL INFORMATION, PAGE 6-4, PROVIDES GENERAL INFORMATION AS TO WHEN TO CALIBRATE THE CELL-DYN 3200. A REVIEW OF COMPLAINTS FOR THE PERIOD OF (B)(4) 2007 THROUGH (B)(4) 2008, DID NOT INDICATE ANY ADVERSE TREND FOR THE CELL-DYN 3200, LIST NUMBER 04H60-01, RELATED TO ISSUES WITH DISCREPANT RESULTS WITH RBC, HGB, MCV, AND HCT. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN 3200, LIST NUMBER 04H60-01, FOR ISSUES RELATED TO DISCREPANT RESULTS WITH RBC, HGB, MCV, AND HCT. THERE WAS NO SYSTEMIC ISSUE IDENTIFIED FOR THE CELL-DYN 3200 PRODUCT LINE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED RESULTS ARE IMPRECISE ACROSS MULTIPLE PARAMETERS ON THE CELL-DYN 3200 ANALYZER. A PATIENT SAMPLE WAS TESTED ON BOTH THE CELL-DYN 3200 AND CELL-DYN RUBY WITH THE FOLLOWING RESULTS: CD 3200 CD RUBYRBC 3.34 M/UL 4.07 M/ULHGB 9.23 G/DL 11.1 M/ULMCV 87.4 FL 93.4 FLHCT 29.2% 38%NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3200 SL 110V ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN

    Patients

    Seq Age Sex Outcome Treatment
    1