BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD1700 CS

    MDR report key: 978486 · Received January 14, 2008

    Report

    Report Number
    2919069-2008-00091
    Event Type
    Other
    Date Received
    January 14, 2008
    Date of Event
    December 26, 2007
    Report Date
    December 26, 2007
    Manufacturer
    ABBOTT DIAGNOSITCS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K870233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: HEMATOCRIT VALUE FOR PATIENT SAMPLE OUT OF CUSTOMER ESTABLISHED RANGE LOW WHEN USING A CELL DYN 1700 ANALYZER. A FIELD SERVICE REPRESENTATIVE VISITED ON 12/26/2007 TO ADDRESS THE ISSUE OF HCT OUT OF RANGE LOW AND TO DO PREVENTIVE MAINTENANCE. THE FSR OBSERVED A CLOT IN THE T FITTING BELOW THE RBC TRANSDUCER. THE FSR CLEANED THE T FITTING AND AS A PRECAUTION REPLACED ALL S1 TUBING FOR THE BUBBLE MIX, REPLACED ALL S2 PINCH TUBING AND REPLACED A SAMPLE SYRINGE AND DILUENT SYRINGE THAT SHOWED SIGNS OF LEAKAGE. PERFORMANCE OF THE INSTRUMENT WAS VERIFIED BY RUNNING PRECISION. ALL CV% WERE IN RANGE. CONTROLS WERE RUN AND PASSED. THE CELL-DYN 1700 SYSTEM OPERATOR'S MANUAL (03H58-01, REV D) DISCUSSES DISPERSION DATA ALERTS ON PAGES, 2-25 3-23. WHEN DISPERSION DATA ALERTS ARE PRESENT IT CAN INDICATE THE NEED FOR THE OPERATOR TO FOLLOW A LABORATORY PROTOCOL, SUCH AS REPEATING THE SAMPLE, PERFORMING A SMEAR REVIEW, OR NOTIFYING A PHYSICIAN. IN CASES WHERE A CELLULAR ABNORMALITY IS PRESENT THAT ALTERS CELLULAR MORPHOLOGY TO THE POINT THAT THE CELLS DO NOT FIT THE CRITERIA USED BY THE INSTRUMENT TO GENERATE A FLAG, DISPERSION DATA ALERTS MAY BE THE ONLY FLAG(S) THAT WILL ALERT THE OPERATOR TO A POTENTIALLY ERRONEOUS RESULT. TRENDING: A REVIEW OF COMPLAINT REPORTS, FOR THE PERIOD MARCH 2007 THROUGH NOVEMBER 2007, DID NOT INDICATE ANY ADVERSE TREND FOR CELL-DYN 1700, LIST BASE 03H53-01 (INCLUDES 03H57-01), ISSUES HCT. LABELING: THE EVENT IS ADDRESSED IN THE CELL-DYN 1700 SYSTEM OPERATOR'S MANUAL, 03H58-01, REV D. SECTION 2: INSTALLATION PROCEDURES AND SPECIAL REQUIREMENTS: SETUP INSTRUCTIONS: PATIENT LIMITS KEYS; P. 2-25 SECTION 3: PRINCIPLES OF OPERATION; OPERATIONAL MESSAGES AND DATA FLAGGING; PARAMETER FLAGGING MESSAGES; DISPERSION DATA ALERTS; P 3-23. CONCLUSION: THE CELL-DYN 1700 WAS EVALUATED AN NO DEVICE FAILURE WAS IDENTIFIED. A VISUAL EXAMINATION WAS PERFORMED AND A CLOT IN THE SYSTEM WAS CAUSING AN OBSTRUCTION TO FLOW. SERVICE RESOLVED THE ISSUE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THIS IS THE FINAL REPORT. END OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE HEMOGLOBIN AND HEMATOCRIT RESULTS FOR ONE PATIENT GENERATED USING A CELL-DYN 1700 CS ANALYZER ARE NOT MATCHING AND THAT THE HEMATOCRIT RESULTS IS OUTSIDE OF THE CUSTOMER ESTABLISHED RANGE. THE RESULTS ARE AS FOLLOWS: HEMOGLOBIN = 16.4 G/DL, CUSTOMER ESTABLISHED RANGE; 12 - 18 G/DL. HEMATOCRIT = 30.3%, CUSTOMER ESTABLISHED RANGE 37 - 51%. RESULTS WERE NOT REPORTED OUT OF THE LAB WITH NO IMPACT TO PATIENT MANAGEMENT REPORTED. SERVICE WAS DISPATCHED TO THE CUSTOMER SITE TO TROUBLESHOOT THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1700 CS AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSITCS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR LOT NO. UNKNOWN| CD17K LYTIC REAGENT LIST NO. 8H19-02