BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 2101347 · Received May 24, 2011

    Report

    Report Number
    2919069-2011-00224
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER TECHNICAL ADVOCATE (CTA) RECOMMENDED CLEANING THE APERTURE PLATES AND RUNNING PRECISION. THE CUSTOMER REPORTED APERTURE PLATES CLEANING HAD BEEN COMPLETED AND THAT PRECISION RUN HAD FAILED. THE CUSTOMER STATED THAT THERE WAS A KINK IN THE LYSE REAGENT LINE AT THE NORMALLY CLOSED VALVE AREA; THE LYSE REAGENT LINE HAD BEEN CLEANED ON THE SAME DAY. THE CUSTOMER REPORTED THAT THERE WERE BUBBLES PRESENT IN THE LYSE SYRINGE AND DILUENT SYRINGE. THE CTA RECOMMENDED MASSAGING THE TUBING, CLEANING THE SYRINGES, AND REPEATING PRECISION. THE CUSTOMER STATED THAT BUBBLES WERE SEEN IN THE SYRINGES EVEN AFTER CLEANING AND STATED THAT THERE WERE NO REPLACEMENT SYRINGES ON-SITE. THE CUSTOMER CONFIRMED THAT NO RESULTS HAVE BEEN RELEASED AND THAT THE OTHER CELL-DYN 1800 INSTRUMENT WAS BEING USED TO REPORT THE RESULTS OUT. THE CTA DISPATCHED SERVICE FOR ISSUE RESOLUTION. A FIELD SERVICE REPRESENTATIVE (FSR) FOUND THAT THE SILICON TUBING (S2) WAS WORN OUT AND DIRTY; THE FSR REPLACED THE SILICON TUBING THROUGHOUT THE FLOW PANEL. THE FSR VERIFIED INSTRUMENT OPERATION, WHICH PASSED. NO FURTHER INVESTIGATION WAS REQUIRED. A REVIEW OF THE CUSTOMER'S DATA SHOWED THAT ALL RUNS HAD UNDERLINED RESULTS WITH EITHER "L", "LL", AND/OR "H" FLAGS, WHICH INDICATED RESULTS OUTSIDE OPERATOR-ENTERED LIMITS. THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL STATES THAT IF THE RESULTS EXCEED THE OPERATOR-ENTERED LIMIT FOR WBC, RBC, HGB, OR PLT, FOLLOW ESTABLISHED LABORATORY OPERATING PROCEDURES. OTHER CORRECTIVE ACTIONS INCLUDE CONFIRMING BACKGROUND DATA, RE-RUNNING SPECIMEN AND IF APPROPRIATE, VIEW STAINED SMEAR TO RECONFIRM COUNT. A NON-STATISTICAL TREND (NST) COMPLAINT REVIEW WAS PERFORMED FOR THE REPORTED ISSUE FROM (B)(4) 2011 THROUGH (B)(4) 2011. NO NST WAS IDENTIFIED DURING THE SEARCHED PERIOD. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN 1800 RELATED TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED EQC SHOWED WBC, RBC, HCT, AND GRAN GREATER THAN 2 SDI ON MULTIPLE LEVELS. HISTORY SHOWED A GRADUAL TREND FOR WBC, RBC AND HCT. THE CUSTOMER NOTED PATIENT HGB/HCT VALUES WERE NOT MATCHING AS CLOSE COMPARED TO A SECOND CELL-DYN 1800 IN THEIR LABORATORY. PATIENT SPECIMENS WERE TESTED ON BOTH INSTRUMENTS AND ONE PATIENT SPECIMEN GENERATED A HEMOGLOBIN VALUE OF 7.5 G/DL ON THE SUSPECT CELL-DYN COMPARED TO 9.6 G/DL ON THE SECOND ANALYZER. RESULTS WERE BEING REPORTED FROM THE SECOND ANALYZER AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1