BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD 1800 ANALYZER

    MDR report key: 2911645 · Received March 26, 2008

    Report

    Report Number
    2919069-2008-00480
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 5, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT, OTHER: SILICON TUBING (S1 - BUBBLE MIX, S2 - PINCH TUBING, S4 TUBING), RETAINER FOR PROBE, WASTE OUTLET TUBE ASSEMBLY (TUBING AND SENSOR WIRE). THE FIELD SERVICE REP (FSR) VISITED ON (B)(4) 2008 AND OBSERVED ISSUES WITH FLOW/CLOGS. SEVEN PARTS WERE REPLACED. THE S1 (SILICON) TUBING FOR THE RBC/PLT BUBBLE MIX WAS REPLACED AS CLOGGED/OBSTRUCTED (HARD FAILURE). S2 SILICON TUBING FOR THE FLOW PANEL PINCH TUBING WAS REPLACED AS WORN OUT (PREVENTIVE MAINTENANCE). S4 SILICON TUBING WAS CHANGED AS A PROACTIVE REPLACEMENT (PREVENTIVE MAINTENANCE). WORN OUT SYRINGES WERE REPLACED (100 UL SAMPLE SYRINGE-PREVENTIVE MAINTENANCE, LEAKING 10 ML DILUENT SYRINGE-HARD FAILURE) THE WASTE CABLE/TUBING WAS REPLACED AS ONE WIRE WAS BROKEN (HARD FAILURE). THE RETAINER FOR THE ASPIRATION PROBE WAS MISSING AND ALSO REPLACED (HARD FAILURE). PRECISION AND CONTROLS WERE RUN AND THE INSTRUMENT WAS PERFORMING WITHIN LABELING CLAIMS. THE CELL-DYN SYSTEM 1800 OPERATOR'S MANUAL, 07H80-01, REV D, PROVIDES A TROUBLESHOOTING GUIDE IN THE INTRODUCTION. A REVIEW OF THE COMPLAINT ANALYSIS TRENDING SYSTEM (CATS) AND TRENDING ANALYSIS SUPPORT SYSTEM (TASS) REPORTS, FOR THE PERIOD JUNE 2007 THROUGH JANUARY 2008, DID NOT INDICATE ANY ADVERSE TREND WITH THE CELL-DYN 1800, LIST BASE 07H77-01, FOR ISSUES WITH DISCREPANT RESULTS ON MULTIPLE PARAMETERS. THERE WAS NO SYSTEMIC ISSUE. THS IS A FINAL REPORT. END OF REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT ONE PT SPECIMEN TESTED CELL-DYN 1800 HEMOGLOBIN = 8.3 G/DL BUT TESTED HEMOGLOBIN = 10.8 G/DL AT A REFERENCE LABORATORY. THE ACCOUNT SUSPECTED AN ASPIRATION ISSUE ON THE CELL-DYN 1800, AS THE SAMPLE HAD TO BE HELD UNDER THE PROBE FOR AN EXTENDED PERIOD BEFORE SAMPLE ASPIRATION BEGAN. ADDITIONALLY, THE ACCOUNT NOTICED SALT BUILD UP ON THE DILUENT SYRINGE. THE CONTROLS WERE RUNNING WITHIN RANGE AND THE MAINTENANCE WAS UP TO DATE ON THE CELL-DYN 1800. SERVICE WAS REQUESTED FOR THE CELL-DYN 1800. THE ACCOUNT DID NOT REPORT THE CELL-DYN 1800 HEMOGLOBIN RESULT OUTSIDE OF THE LABORATORY. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK