BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2183491 · Received July 29, 2011

    Report

    Report Number
    1628664-2011-00555
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    June 29, 2011
    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

    PREVIOUS INVESTIGATIONS HAVE SHOWN A DEFICIENCY OF THE ARCHITECT SYSTEM EXISTS IN THAT THE I2000SR RECEIVED 2 CONSECUTIVE SAMPLE IN POSITION MESSAGES WITHOUT RECEIVING A SAMPLING COMPLETE MESSAGE AFTER THE FIRST SAMPLE. 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)(6) 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. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES CORRECTIVE ACTIONS FOR ERROR CODE 8275.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE DISPLAYS ERROR MESSAGE. (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED ERROR CODE 8275, SAMPLE PRESENTATION ERROR, OCCURRED ON A SAMPLE ON THE ARCHITECT (B)(4) CONNECTED TO THE ACCELERATOR AUTOMATED PROCESSING SYSTEM (APS). SAMPLE ID # (B)(6) WAS SENT, WHILE SAMPLE ID # (B)(6) WAS IN THE SAMPLING POSITION. THE RESULT WAS NOT VALIDATED BY THE MIDDLEWARE AND THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 SERIAL # (B)(4)| ACCELERATOR APS IOM LIST # 7L01-51| SERIAL # (B)(4)| ACCELERATOR APS IOM LIST # 7L01-51