BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1933097 · Received December 20, 2010

    Report

    Report Number
    1628664-2010-00492
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INITIAL REPORT WAS SUBMITTED UNDER BRAND NAME ABBOTT ARCHITECT SYSTEM, (B)(4) MANUFACTURING SITE. IT WAS DETERMINED THAT THE INVESTIGATION SHOULD BE PERFORMED ON BRAND NAME (B)(4) MANUFACTURING SITE. NO SIMILAR PRODUCT IS DISTRIBUTED FOR SALE IN THE UNITED STATES. THE UPDATED INFORMATION DOES NOT FIT ESTABLISHED CRITERIA FOR A REPORTABLE EVENT. THIS CORRECTED/UPDATED REPORT IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT (B)(4) ANALYZER GENERATED A FALSE NEGATIVE SYPHILIS RESULT FOR ONE PATIENT SAMPLE. THE ARCHITECT ANALYZER GENERATED AN INITIAL NEGATIVE SYPHILIS RESULT OF APPROXIMATELY 0.5 S/CO. THE SAMPLE WAS CONFIRMED POSITIVE BY ANOTHER UNSPECIFIED METHOD. THE FALSE NEGATIVE SYPHILIS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC. 94133LP08

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR: LN 3M74-02, SN (B)(4)