BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD1800 ANALYZER

    MDR report key: 1038412 · Received May 6, 2008

    Report

    Report Number
    2919069-2008-00537
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Report Date
    April 8, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTED THAT QC WAS DRIFTING UP AND DOWN FOR HGB AND THE CUSTOMER SUSPECTED AN IMPRECISION ISSUE. THE CUSTOMER REQUESTED A SERVICE VISIT. A FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED AND FOUND THE HGB FLOWCELL READING WAS OUT OF RANGE. THE FLOW CELL WAS CLEANED, FLUSHED, AND DECONTAMINATED. CONTROLS WERE RUN AND PASSED. THE CELL-DYN SYSTEM 1800 OPERATOR'S MANUAL 07H80-01, REV D: HGB IMPRECISION MAY BE CAUSED BY A CONTAMINATED FLOWCELL (10-36). THE FLOWCELL IS CLEANED DURING THE AUTOCLEAN PROCEDURE (WEEKLY MAINTENANCE, P. 9-19, 9-20) BUT MAY ALSO BE CLEANED SEPARATELY AS DESCRIBED IN SECTION 9, PAGES 9-35 TO 9-38. IN ADDITION A REVIEW OF THE COMPLAINT ANALYSIS TRENDING SYSTEM (CATS) AND TRENDING ANALYSIS SUPPORT SYSTEM (TASS) REPORTS WAS PERFORMED AND NO ADVERSE TRENDS WERE IDENTIFIED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE CELLDYN 1800 ANALYZER GENERATED A HEMOGLOBIN (HGB) RESULT OF 8.1 G/DL WITH A HEMATOCRIT (HCT) OF 39%. THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED AND THE HGB WAS 13.3 G/DL. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK