BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1083126 · Received July 24, 2008

    Report

    Report Number
    1628664-2008-00179
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Report Date
    July 2, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    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 COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT WITH CLINICAL FINDINGS SUGGESTING A HEPATITIS A INFECTION GENERATED A NON-REACTIVE ARCHITECT HAVAB-IGM INDEX RESULT OF 0.39. THE PATIENT IS JAUNDICED WITH VERY ELEVATED AST AND ALT RESULTS. THE PATIENT WAS HOSPITALIZED, WHERE TESTING WAS REACTIVE FOR HABAB-IGM. A SECOND SAMPLE WAS DRAWN AND GENERATED AN ARCHITECT HAVAB-IGM INDEX RESULT OF 0.66 (NON-REACTIVE). THIS SECOND SAMPLE GENERATED A REACTIVE RESULT ON THE AXSYM AND DIASORIN PLATFORMS. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR ARCHITECT HAVAB IGM ASSAY| AND 60318HN00| LOT#: 59153HN00