BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1700 CS ANALYZER

    MDR report key: 1221443 · Received November 7, 2008

    Report

    Report Number
    2919069-2008-00770
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K870233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). A FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THE ACCOUNT. THE FSR CHANGED THE PERIPUMP TUBING AND CLEANED THE CLOSED MODE. THE FSR ALSO REPLACED A WORN OUT CLOSED SAMPLE DETECTOR ON THE CAP PIERCER, PERFORMED SAMPLE SENSOR ALIGNMENT, REPLACED A CLOGGED NEEDLE DRIVE ASSEMBLY, AND VERIFIED ALL GAINS. PRECISION AND QC WERE RUN AND WERE WITHIN SPECIFICATIONS. LABELING REVIEW THE CELL-DYN 1700 SYSTEM OPERATOR'S MANUAL, LIST NUMBER 03H58-01, REVISION F, UNDER SECTION 9, SERVICE AND MAINTENANCE, NONSCHEDULED MAINTENANCE FREQUENCY, PAGE 9-19, INDICATES THAT THE SAMPLE ASPIRATION PROBE INTERIOR SHOULD BE CLEANED WHEN IT IS SUSPECTED OF BEING THE SOURCE OF IMPRECISION. ASPIRATION PROBE REMOVAL AND REPLACEMENT SHOULD BE PERFORMED WHEN THERE IS A NON-REMOVABLE OBSTRUCTION IN THE PROBE. SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS, PAGE 10-9, PROVIDES BASIC TROUBLESHOOTING TO ASSIST THE OPERATOR IN IDENTIFYING, ISOLATING AND RESOLVING INSTRUMENT PROBLEMS. SECTION 13, CELL-DYN 1700CS, CLOSED SAMPLE ASPIRATION, SYSTEM COMPONENTS, CLOSED SAMPLE ASSEMBLY, PAGES 13-3 THROUGH 13-4, PROVIDES INFORMATION IN REGARDS TO THE CLOSED SAMPLE ASPIRATION ASSEMBLY AND ITS EXTERIOR AND INTERIOR COMPONENTS. A REVIEW OF THE COMPLAINT ANALYSIS TRENDING SYSTEM (CATS) AND TRENDING ANALYSIS SUPPORT SYSTEM (TASS) REPORTS WAS PERFORMED AND NO ADVERSE TREND RELATED TO DISCREPANT RESULTS WITH PATIENT SAMPLES IN CLOSED MODE WAS IDENTIFIED. NO MALFUNCTION WAS IDENTIFIED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE CELL-DYN 1700 ANALYZER GENERATED THE FOLOWING RESULTS IN THE CLOSED MODE: WBC=3,400/UL, RBC=2.85X10E6/UL, HGB=8.4 G/DL, PLT=145,000/UL. THE SAMPLE WAS REPEATED IN THE OPEN MODE WITH THE FOLLOWING RESULTS: WBC=4,000/UL, RBC=3.37X10E6/UL, HGB=9.9 G/DL, PLT=180,000/UL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR