BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1920293 · Received December 10, 2010

    Report

    Report Number
    1628664-2010-00478
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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. 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

    THE CUSTOMER STATED SAMPLE PRESENTATION ERROR 8275 OCCURRED ON AN ARCHITECT I2000SR ANALYZER. LAST SENT SID "HBCAB POS" TO THE ACCELERATOR WHEN SID "HBCAB NEG" IN THE SAMPLING POSITION. 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 APS IOM LN 7L01 SN (B)(4)| APS IOM LN 7L01 SN (B)(4)