BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNQUEST LABORATORY SMART

    MDR report key: 2082158 · Received April 29, 2011

    Report

    Report Number
    2029302-2011-00002
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    SUNQUEST INFORMATION SYSTEMS
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIFTY SITES HAVE BEEN NOTIFIED VIA A PRODUCT SAFETY NOTICE (PSN) AND A CORRECTION IS AVAILABLE FOR SUNQUEST LABORATORY VERSIONS 6.3.0 SP7, 6.4.3 AND 7.0.0. THERE ARE 0 SITES THAT HAVE ALREADY BEEN CORRECTED. A RECOMMENDED WORKAROUND IS TO USE LARS INSTEAD OF ONLINE ENTRY WHEN ENTERING RESULTS FOR INSTRUMENT METHOD CODES THAT ARE DEFINED TO USE REPLICATE TESTS THAT ARE TYPICALLY ORDERED ON THE SAME ACCESSION. METHOD: COMPUTER SOFTWARE PROGRAM CODE EVALUATED.

    Description of Event or Problem · 1

    IN ONLINE ENTRY (OEX) THERE ARE TWO SCENARIOS WHERE A TEST RESULT FROM ONE CONTAINER MAY FILE TO A TEST ON ANOTHER CONTAINER. IN ORDER FOR THIS TO OCCUR: SITE PARAMETER SIT 1,2,1,26 (3,217) [RESTRICT RESULTING OF TESTS TO OWNER CONTAINER (<Y>/N)]='Y'. THE TESTS ARE ORDERED ON THE SAME ACCESSION NUMBER. THE TEST CODES ARE DEFINED TO HAVE THE SAME UPLOAD CODE AS EITHER REPLICATE OR SUBTESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNQUEST LABORATORY SMART SMART AND SMART SELECT JQP SUNQUEST INFORMATION SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1