BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1962129 · Received January 17, 2011

    Report

    Report Number
    2919069-2011-00028
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 5, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT TO EVALUATE THIS ISSUE. THE FSR REPLACED A FAULTY PREAMPLIFIER PCB ASSEMBLY, THE CELL COUNT MODEL PCB ASSEMBLY, THE HGB FLOW CELL AND THE SILICON TUBING ALONG THE FLOW PANEL. THE FSR PERFORMED ALL THE APPROPRIATE VERIFICATION PROCESS AND VERIFIED PROPER INSTRUMENT OPERATION. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY COMPLAINTS WITH AN ADVERSE TREND RELATED TO THIS PRODUCT. THE CUSTOMER WAS REFERRED TO THE OPERATORS MANUAL FOR INFORMATION IN ASSISTING PROBLEM IDENTIFICATION, ISOLATION AND CORRECTIVE ACTIONS. THE OPERATORS MANUAL ALSO INSTRUCTED THE USER TO SEEK A TECHNICAL SUPPORT FOR ADDITIONAL INFORMATION OR HELP. NO PRODUCT DEFICIENCY WAS IDENTIFIED RELATED TO THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE CELL-DYN ANALYZER GENERATED A LOWER THAN EXPECTED PATIENT RESULT FOR THE HEMOGLOBIN (2.1 G/DL). THE RESULT WAS NOT FLAGGED BY THE ANALYZER AS SUSPECT AND IT WAS NOT REPORTED OUT. THE TEST WAS REPEATED AND EXPECTED HEMOGLOBIN RESULT WAS GENERATED (13.7 G/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMOGLOBIN| HEMOGLOBIN