BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNQUEST LABORATORY LABACCESS RESULTS WORKSTAT

    MDR report key: 1922754 · Received November 12, 2010

    Report

    Report Number
    2029302-2010-00002
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 10, 2010
    Manufacturer
    SUNQUEST INFORMATION SYSTEMS
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ABOUT 129 SITES HAVE BEEN NOTIFIED VIA A (B)(4) AND A CORRECTION IS AVAILABLE IN (B)(4). THERE ARE 22 SITES THAT HAVE ALREADY BEEN CORRECTED. THE (B)(4) NOTICE INCLUDES A RECOMMENDED WORK-AROUND WHICH IS TO TURN OFF AUTO-UPDATE IN SINGLE SPECIMEN VIEW. THIS ADDRESS THE RISK OF THE ISSUE. METHOD: COMPUTER SOFTWARE PROGRAM CODE EVALUATED.

    Description of Event or Problem · 1

    (B)(6) MAY FILE RESULTS TO THE WRONG PATIENT BY INCORRECTLY COMBINING RESULTS. THIS PROBLEM HAPPENS IN SINGLE SPECIMEN VIEW AND WHEN UPDATE IS ACTIVATED; HOWEVER, IT IS UNCOMMON FOR THIS PROBLEM TO OCCUR DUE TO TIMING OF THE AUTO UPDATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNQUEST LABORATORY LABACCESS RESULTS WORKSTAT LARS JQP SUNQUEST INFORMATION SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1