BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPECO SYSTEM

    MDR report key: 1992196 · Received February 15, 2011

    Report

    Report Number
    1628664-2011-00072
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    January 26, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    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). 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

    THE CUSTOMER STATED ERROR 8275 OCCURRED ON AN (B)(4) SYSTEM. THE SYSTEM RELEASED AN INCORRECT PROLACTIN RESULT OF 390 MIU/L FOR (B)(6) WHEN (B)(6) HAD BEEN SAMPLED. (B)(6) WAS RERUN AND A PROLACTIN RESULT OF 122 MIU/L WAS GENERATED. NO RESULT WAS GENERATED FOR (B)(6). THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INPECO SYSTEM AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM JQP ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR LN 3M74-02 (B)(4)