BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1862700 · Received October 8, 2010

    Report

    Report Number
    1628664-2010-00361
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION WAS CONDUCTED TO EVALUATE THIS ISSUE. THE CUSTOMER REQUESTED SERVICE AND AN ABBOTT FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT. THE FSE PERFORMED SOME MAINTENANCE PROCEDURE (GRAVIMETRIC TESTS FOR WASH ZONES 1 AND 2, PERFORMED RESIDUAL TEST ON THE WASH ZONES, REPLACED WASH ZONE MANIFOLD VALVE 2, PERFORMED PIPETTER CALIBRATIONS FOR THE SAMPLE REAGENT PIPETTERS AND PERFORMED QUALITY CONTROL ANALYSIS FOR THE HCV ASSAY). THE FSE CONFIRMED THE INSTRUMENT SATISFACTORY PERFORMANCE UPON DEPARTURE. THE INSTRUMENT HISTORY WAS REVIEWED AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED FOR ERRATIC RESULTS RELATED TO THIS INSTRUMENT. BASED ON THE INVESTIGATION RESULTS, NO MALFUNCTION OR PRODUCT DEFICIENCY WERE IDENTIFIED RELATED TO THIS ISSUE. HOWEVER, THE CUSTOMER WAS REFERRED TO THE INSTRUMENT LABELING WHERE SUCH AN ISSUE OF DISCREPANT RESULTS WAS DISCUSSED ALONG WITH THE PROBABLE CAUSES.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED DISCREPANT RESULTS FROM SAMPLES OF THREE PATIENTS. A SAMPLE FROM ONE PATIENT GENERATED A FALSE NEGATIVE RESULT FOR THE HIV AG ASSAY WHICH WAS REPEATED POSITIVE. NO IMPACT TO THE PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED A (B)(6) RESULT FOR THE ANTI-HCV ASSAY FROM ONE PATIENT SAMPLE. THE RESULT WAS REPEATED (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 HCV AG REAGENT| ANTI-HCV REAGENT 6C37-30