BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD1800 ANALYZER

    MDR report key: 874745 · Received June 29, 2007

    Report

    Report Number
    2919069-2007-00080
    Event Type
    Other
    Date Received
    June 29, 2007
    Date of Event
    June 1, 2007
    Report Date
    June 4, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: DISCREPANT HEMOGLOBIN (HGB) RESULTS (CELL-DYN 1800 ANALYZER VERSUS HOSPITAL RESULT). THE INITIAL DISCREPANT TESTING RESULTS, OBTAINED IN 2007 WERE TAKEN FROM 2 DIFFERENT DRAW SITES, PORT VERSUS VENOUS. CUSTOMER SUPPORT SUGGESTED THE CUSTOMER PERFORM A CALIBRATION VERIFICATION. THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL DATA AS NO CALIBRATOR WAS AVAILABLE. CALIBRATOR WAS SENT TO THE CUSTOMER BUT TESTING WAS NOT DONE BECAUSE THE INSTRUMENT WAS NOT AVAILABLE DUE TO ANOTHER NON-RELATED ISSUE WHICH WAS LATER RESOLVED BY FIELD SERVICE. THE DISCREPANT HEMOGLOBIN ISSUE WAS CLOSED AS RESOLVED THOUGH CUSTOMER INTERACTION/INSTRUCTION. THE PATIENT RETURNED TO THE HOSPITAL ON THREE DAYS LATER, AND A SPECIMEN WAS DRAWN FOR CBC YIELDING A HGB RESULT OF 8.9 G/DL. THE VIAL WAS SENT TO THE HOSPITAL WHERE A HGB OF 9.6 WAS OBTAINED. ALL QC WAS IN RANGE ON THE SAME DAY. THE RESULTS ON THE CD1800 SHOWED OUT OF RANGE (CUSTOMER ACTION LIMITS) LOW RESULTS FOR RBC, HGB, HCT, MCV, MCHC, RDW. PATIENT RANGE FOR HGB WAS 12.0 TO 18.0 G/DL. THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL (07H80-01, REV D) RECOMMENDS ON 3-25 THAT: A RESULT THAT FALLS OUTSIDE A LABORATORY ACTION LIMIT CAN ALSO INDICATE THE NEED FOR THE OPERATOR TO FOLLOW A LABORATORY PROTOCOL, SUCH AS REPEATING THE SAMPLE, PERFORMING A SMEAR REVIEW OR NOTIFYING THE PHYSICIAN. TRENDING REVIEW: A REVIEW OF COMPLAINT REPORTS, FOR THE PERIOD NOVEMBER 2006 THROUGH MAY 2007, DID NOT INDICATE ANY ADVERSE TREND FOR CELL-DYN 1800, LIST BASE 07H77-01 FOR ISSUES WITH DISCREPANT HGB RESULTS. LABELING: THE EVENT IS ADDRESSED IN THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL 07H80-01, REV D: SECOND 3 PRINCIPLES OF OPERATION: SYSTEM INITIATED MESSAGES AND DATA FLAGS: DISPERSIONAL DATA ALERTS: P 3-25. CONCLUSION: THE DEVICE, CELL-DYN 1800 ANALYZER, WAS EVALUATED WITH NO FAILURE DETECTED AND PRODUCT WAS FOUND TO BE PERFORMING WITHIN SPECIFICATIONS. ALL QC WAS WITHIN RANGE AND THE ANALYZER PERFORMED WELL ON PROFICIENCY TESTING. THE PHYSICIAN AT THE CUSTOMER FACILITY HAD CONFIDENCE IN THE PERFORMANCE OF THE INSTRUMENT. SPECIMEN COLLECTION AND HANDLING TECHNIQUES AND THE NEED FOR THE ANALYZER TO BE CALIBRATED MAY HAVE CAUSED OR CONTRIBUTED TO THE HEMOGLOBIN DISCREPANCY ISSUE WHICH WAS RESOLVED BY CUSTOMER EDUCATION/INSTRUCTION BY THE CUSTOMER TECHNICAL ADVOCATE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A SAMPLE DRAWN IN 2007 FROM ONE PATIENT DIAGNOSED WITH LYMPHOMA GENERATED A HEMOGLOBIN RESULT OF 8.3 G/DL USING A CELL-DYN 1800 ANALYZER. THE PATIENT WAS SENT TO THE HOSPITAL FOR A TRANSFUSION WHERE ANOTHER SAMPLE WAS DRAWN OBTAINING A HEMOGLOBIN RESULT OF 9.3 G/DL (METHOD NOT PROVIDED). THE PHYSICIAN DECIDED NOT TO PERFORM A TRANSFUSION. THE PATIENT RETURNED TO THE PHYSICIAN'S OFFICE ON THREE DAYS LATER, AND A BLOOD SPECIMEN WAS DRAWN OBTAINING A HEMOGLOBIN OF 8.9 G/DL. THE SPECIMEN WAS SENT TO THE HOSPITAL AND TESTED OBTAINING A HEMOGLOBIN OF 9.6 G/DL. PATIENT INFORMATION REGARDING AGE WAS APPROXIMATE AND NO INFORMATION WAS PROVIDED REGARDING PATIENT'S WEIGHT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR