BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 851329 · Received May 11, 2007

    Report

    Report Number
    1628664-2007-00243
    Event Type
    Other
    Date Received
    May 11, 2007
    Date of Event
    April 19, 2007
    Report Date
    April 19, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT PT SAMPLES WERE BEING RUN ON THE ARCHITECT I2000 PROCESSING MODULE AND ALTHOUGH PT SAMPLES WERE SAMPLED, THEIR STATUS REMAINED PENDING. AN ANTI-HBC S/CO RESULT OF 0.1 (NON-REACTIVE) WAS GENERATED FOR A PT SAMPLE THAT RETESTED AT 8.6 S/CO (REACTIVE). THE CUSTOMER BELIEVES THAT THE CAUSE OF THIS ISSUE IS A MIS-COMMUNICATION BETWEEN THE NON-ABBOTT LABORATORY AUTOMATION SYSTEM (LAS) AND THE ARCHITECT I2000 SYSTEM CONTROL CENTER (SCC). A REVIEW OF THE INSTRUMENT LOGS FOUND THAT A "TIME-OUT" ERROR OCCURRED NEAR THE TIME OF THE PRESENT ISSUE. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR ARCHITECT ANTI-HBC ASSAY LIST#: 7C17