BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 1700

    MDR report key: 801443 · Received December 2, 2004

    Report

    Report Number
    2919069-2004-00095
    Event Type
    Other
    Date Received
    December 2, 2004
    Date of Event
    October 5, 2004
    Report Date
    December 1, 2004
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT CONTACTED A CUSTOMER TECHNICAL ADVOCATE (CTA) STATING THAT A PATIENT'S CBC RESULT GENERATED USING A CELL-DYN 1700 ANALYZER DID NOT MATCH THE CBC RESULTS THAT WAS DRAWN AT THE EMERGENCY ROOM (ER) IN 2004. THERE ARE DISPERSIONAL DATA ALERTS ON THE PRINTOUT FOR THE MCH, MCHC, AND RDW PARAMETERS. THE ACCOUNT MIXED THE SAMPLE AND RAN THE SPECIMEN IMMEDIATELY AFTER COLLECTION. THE QUALITY CONTROL WAS WITHIN RANGE THE DAY THE SPECIMEN WAS RUN. THE ACCOUNT'S MAINTENANCE LOG SHOWED THAT MAINTENANCE WAS PERFORMED. THE ACCOUNT DID NOT EXPERIENCE ANY INSTRUMENT ISSUES AROUND THE TIME THE RESULT WAS GENERATED. THE SAMPLE BEFORE AND AFTER THE PATIENT SPECIMEN WAS NOT AFFECTED. THE CTA REVIEWED THE INSTRUMENT HISTORY AND THE ACCOUNT HAS NOT EXPERIENCED ANY ISSUE WITH RESULTS SINCE THAT DAY. THE ACCOUNT SENT OUT A RANDOM SAMPLE TO A REFERENCE LAB THE FOLLOWING MONTH, TO VERIFY THAT THE REFERENCE LAB RESULTS WOULD MATCH THE CELL-DYN 1700 RESULTS. THE RESULTS MATCHED THE CELL-DYN 1700 RESULTS. IT IS INCONCLUSIVE WHAT CAUSED THE ERRATIC RESULTS ON ORIGINAL DATE. IT IS UNK IF A MALFUNCTION OCCURRED. TRENDING ANALYSIS: A REVIEW OF THE COMPLAINT TRENDING ANALYSIS FOR THE MONTHS OF THREE MONTHS IN 2004 DID NOT INDICATE AN ADVERSE TREND FOR THIS ISSUE OF THE CELL-DYNO 1700 SYSTEM. LABELING: THE ISSUE IS ADDRESSED IN THE CELL-DYN SYSTEM 1700 OPERATOR'S MANUAL, PRINCIPLES OF OPERATION, OPERATIONAL MESSAGES AND DATA FLAGGING / OVERVIEW SECTION AND IN THE OPERATIONAL MESSAGES AND DATA FLAGGING / PARAMETER FLAGGING MESSAGES SECTION. IN ADDITION, THE ISSUE IS ADDRESSED IN THE TROUBLESHOOTING AND DIAGNOSTICS, TROUBLESHOOTING GUIDE / ABNORMAL OR ERRATIC HGB, MCH, AND/OR MCHC RESULTS SECTION OF THE MANUAL. THIS IS THE FINAL REPORT. END OF REPORT.

    Description of Event or Problem · 1

    A CUSTOMER TECHNICAL ADVOCATE WAS CONTACTED WITH REGARD TO CBC RESULTS GENERATED ON A PATIENT USING A CELL-DYN 1700 ANALYZER. A HEMOGLOBIN RESULT OF 15.8 G/DL WAS REPORTED AND QUESTIONED BY A MEDICAL PRACTITIONER. THE PATIENT WAS SENT TO THE EMERGENCY ROOM BECAUSE THE RESULTS OF AN X-RAY SHOWED A LUNG MASS. A BLOOD SPECIMEN DRAWN AT THE EMERGENCY ROOM YIELDED A HEMOGLOBIN VALUE OF 8.5 G/DL. APPROXIMATELY ONE HOUR LATER, A SECOND SAMPLE WAS DRAWN FROM THIS PATIENT IN THE EMERGENCY ROOM THAT YIELDED A HGB= 8.7 G/DL RESULT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1700 AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR