BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPECO SYSTEM

    MDR report key: 2123881 · Received June 14, 2011

    Report

    Report Number
    3002809144-2011-00500
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ABBOTT GERMANY
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    THE CUSTOMER STATED WHILE RUNNING PATIENT SAMPLES ON THE ARCHITECT I2000 SR ANALYZER, RECEIVED ERROR CODE 8275 (SAMPLE PRESENTATION ERROR. LAS SENT SID (X), WHEN SID (Y) IN SAMPLING POSITION), WHICH IS DISPLAYED ON THE SCREEN OF THE ARCHITECT SYSTEM CONTROL CENTER. THE CUSTOMER NOTED THAT THE LAS SENT SID (B)(6) INSTEAD OF THE CORRECT SID OF (B)(6). THE CUSTOMER REPEATED ALL TESTS FOR BOTH SAMPLES AND NO INCORRECT RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INPECO SYSTEM JQP ABBOTT GERMANY

    Patients

    Seq Age Sex Outcome Treatment
    1 SERIAL # (B)(4)| ARCHITECT I2000SR LIST # 3M74-11| ARCHITECT I2000SR LIST # 3M74-11 SERIAL # (B)(4)