BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1905647 · Received November 23, 2010

    Report

    Report Number
    1628664-2010-00433
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO INVESTIGATE THE ISSUE, THE COMPLAINT TEXT, THE INSTRUMENT HISTORY, AND ARCHITECT SYSTEM LABELING WERE REVIEWED. AFTER FIELD SERVICE REPLACED THE SAMPLE PROBE, THE INSTRUMENT RETURNED TO RUNNING WITHIN SPECIFICATIONS. NO ADDITIONAL OCCURRENCES OF DISCREPANT SYPHILIS TP RESULTS HAVE BEEN OBSERVED. THE REVIEW SHOWED THE PRODUCT LABELING DOES ADDRESS OPERATIONAL PRECAUTIONS, LIMITATIONS, AND ERRATIC RESULTS INCLUDING PROBABLE CAUSES AND CORRECTIVE ACTIONS. NO ADVERSE TREND WAS IDENTIFIED RELATED TO THIS ISSUE. THE SERVICE HISTORY REVIEW DID NOT IDENTIFY ANY PREVIOUS INCIDENTS OF THE ARCHITECT I2000SR, (B)(4), GENERATING DISCREPANT RESULTS OR IMPRECISE CONTROLS DURING THIS TIME FRAME. NO ADDITIONAL ERRATIC OCCURRENCES WERE OBSERVED SINCE THE COMPONENT REPLACEMENT OF THE SAMPLE PROBE. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A PATIENT SPECIMEN PROCESSED USING THE ARCHITECT SYPHILIS TP ASSAY GENERATED A FALSELY (B)(6). THE SAMPLE WAS TESTED USING AN ALTERNATE METHOD (TPHA) YIELDING A (B)(6). THE SAMPLE WAS ALSO REPEATED ON THE ARCHITECT YIELDING A (B)(6). NO ADVERSE OUTCOMES WERE REPORTED RELATED TO THIS ISSUE.

    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 ARCHITECT SYPHILIS TP LN 8D06-20 LOT # UNK| ARCHITECT SYPHILIS TP LN 8D06-20 LOT # UNK