BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 1200 ANALYZER

    MDR report key: 735679 · Received July 15, 2005

    Report

    Report Number
    2919069-2005-00049
    Event Type
    Other
    Date Received
    July 15, 2005
    Date of Event
    June 17, 2005
    Report Date
    July 14, 2005
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TROUBLESHOOTING WITH THE CUSTOMER, THE CUSTOMER TECHNICAL ADVOCATE (CTA) FOUND THAT THE HEMOGLOBIN (HCB) REFERENCE VALUE WAS OUT OF RANGE LOW AT 1118 (2000 +/- 200), AND THE MIXING CUPS WERE DIRTY. THE CTA REQUESTED THAT THE CUSTOMER CLEAN THE APERTURE PLATE, RUN A BACKGROUND AND PERFORM A PRECISION STUDY. PER THE CUSTOMER DATA, THE PRECISION STUDY PERFORMED ON 6/18/2005 SHOWED PARAMETERS OUT OF SPECIFICATION FOR %CV. SERVICE WAS SENT TO THE ACCOUNT AND THE TECHNICAL EXECUTIVE (TE) NOTICED THE PRE-MIX CUP OVER BUBBLING WHICH MAY HAVE CREATED BUBBLES IN THE HGB FLOW CELL. THIS IN TURN MAY HAVE RESULTED IN THE LOW HGB REFERENCE VALUE AND THE ISSUE OF LOW HGB RECOVERY. THE TE REPLACED THE HGB FLOW CELL AND THE ADJACENT TUBINGS TO RESOLVE THE ISSUES. THERE HAVE BEEN NO FURTHER ISSUES SINCE THE SERVICE VISIT. IN ADDITION, THE COMPLAINT ANALYSIS AND TRENDING SYSTEM (CATS) AND THE TRENDING ANALYSIS SUPPORT SYSTEM (TASS) WERE REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CELL DYN 1200 ANALYZER GENERATED A HEMOGLOBIN (HCB) RESULT OF 7.9 G/DL WHICH WAS REPORTED. THE SAMPLE WAS SENT OUT AND IRON STUDIES WERE ORDERED ON THE PT. THE HGB RESULT FROM THE REFERENCE LAB WAS 12.2 G/DL. THERE WAS NO ADVERSE IMPACT TO PT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1200 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR