BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 1840544 · Received September 21, 2010

    Report

    Report Number
    1628664-2010-00334
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND REPLACED THE SAMPLE PROBE, CLEANED THE VORTEXER AND WASH ZONE MANIFOLD, CHECKED THE WASH ZONE CONDITION AND FOUND IT ACCEPTABLE, AND PERFORMED A VACUUM SYSTEM TEST, WHICH PASSED. NO FURTHER REPORTS OF UNRESOLVED ERRATIC RESULTS HAVE BEEN REPORTED. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT SYSTEM OPERATIONS MANUAL P/N 201837-106, JANUARY 2009 CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE AVAILABLE INFORMATION A SINGLE DEFINITIVE CAUSE OF THE ERRATIC/ELEVATED RESULTS WAS NOT DETERMINED, NOR WAS A DEFICIENCY OF THE ARCHITECT I2000 ANALYZER IDENTIFIED. REVIEW OF COMPLAINT TRACKING AND TRENDING.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED AN INITIAL ARCHITECT PSA ASSAY RESULT OF 6.1 NG/ML THAT RETESTED AT 3.5 NG/ML. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH TOTAL PSA: LN: 7K70| ARCH TOTAL PSA: LN: 7K70