BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1992190 · Received February 15, 2011

    Report

    Report Number
    1628664-2011-00071
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    August 30, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. INVESTIGATIONS HAVE SHOWN A DEFICIENCY OF THE ARCHITECT SYSTEM EXISTS IN THAT MESSAGES ARE NOT PROCESSED WITHIN THE EXPECTED TIME PERIOD. THE SOFTWARE SHOULD BE CHANGED TO RECALCULATE THE TIME PERIOD MEASURED. THE 8275 ERROR MESSAGE OCCURS WHEN A SAMPLE IS UNEXPECTEDLY DETECTED AT THE SAMPLING POSITION, BUT THE TESTS ARE ALLOWED TO PROCESS TO COMPLETION. (B)(4) WILL ADDRESS THE ISSUE BY DEVELOPING NEW FIRMWARE THAT WILL DELETE EXTRA PENDING MESSAGES AND AVOID THE 8275 ERROR. ARCHITECT SYSTEM SOFTWARE WILL BE UPDATED TO SEND SAMPLES AFFECTED BY ERROR CODE 8275 TO EXCEPTIONS. THE COMPLAINT ISSUE INVOLVES THE INTERACTION BETWEEN THE ACCELERATOR APS AND THE ARCHITECT SYSTEMS. TRACKING AND TRENDING IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE.

    Description of Event or Problem · 1

    AN ARCHITECT I2000SR ANALYZER GENERATED ERROR CODE 8275. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH SCC CPU LN 7D01-06