BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 772764 · Received August 16, 2006

    Report

    Report Number
    1225673-2006-00001
    Event Type
    Malfunction
    Date Received
    August 16, 2006
    Report Date
    August 14, 2006
    Manufacturer
    DATA INNOVATIONS, INC.
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    ACTION TAKEN: SITE REPORTING THE PROBLEM HAS BEEN CONTACTED WITH INFO ABOUT THE ISSUE, AND INFORMED OF THE TEMPORARY SOLUTION TO USE TO PREVENT THE PROBLEM. CUSTOMERS HAVE BEEN NOTIFIED OF THE ISSUE AND TEMPORARY SOLUTION VIA OUR ALERT LISTSERV AS PER OUR ESTABLISHED PROCEDURES. WORK ON THE SOFTWARE PATCH HAS BEGUN. ACTIONS TO BE TAKEN: A LETTER DESCRIBING THIS ISSUE AND RESOLUTION WILL BE SENT TO THE CUSTOMER BASE AFFECTED BY THIS ISSUE. THE SOFTWARE PATCH WILL BE COMPLETED BY 09/8/2006. THE SOFTWARE PATCH WILL BE MADE AVAILABLE FOR DOWNLOAD FROM OUR WEBSITE, AS PER OUR ESTABLISHED PROCEDURES. DATA INNOVATIONS WILL ASSIST ANY CUSTOMER WITH QUESTIONS OR NEEDING ASSISTANCE WITH APPLYING THE PATCH.

    Description of Event or Problem · 1

    ISSUE: A BUG IN THE INSTRUMENT MANAGER SOFTWARE CAN LEAD TO CLINICAL TEST DATA BEING ASSOCIATED WITH THE WRONG SPECIMEN. A PROBLEM WITH THE RESULTS REVIEW/EDIT/RELEASE SCREEN OF THE SOFTWARE ALLOWS TEST DATA TO BE ASSOCIATED WITH AN INCORRECT SPECIMEN. DETAILS: DURING THE LOADING OF TESTS FOR A SPECIMEN IN RESULTS REVIEW/EDIT/RELEASE, SELECTING ANOTHER SPECIMEN WHILE THE SEARCH OR STATUS DIALOG BOXES ARE DISPLAYED WILL RESULT IN THE TESTS FOR THE FIRST SPECIMEN BEING DISPLAYED FOR THE LAST SPECIMEN SELECTED. THIS OCCURS IN THE FOLLOWING SITUATION: THE USER SELECTS A SPECIMEN AND BEFORE THE TESTS FOR THAT SPECIMEN ARE FINISHED LOADING INTO THE TESTS GRID, THE USER SELECTS ANOTHER SPECIMEN. THE RESULT IS THAT THE CURRENT SPECIMEN SELECTED IN THE SPECIMENS GRID IS DISPLAYING TESTS FOR THE PREVIOUSLY SELECTED SPECIMEN. IF TEST DATA IS MODIFIED AND SAVED, THE RESULTS WILL BE SAVED TO THE INCORRECT SPECIMEN AND THE AUDIT TRAIL SHOWS THAT THE USER MODIFIED THE DATA. THIS ACTION MAY ONLY BE DISCOVERED WHEN RESULTS ARE REVIEWED IN THE LIS. THE SITE REPORTING THIS ISSUE TO DATA INNOVATIONS DISCOVERED IT AS THEY CHECKED RESULTS IN THEIR LIS, AND SO NO HARM WAS CAUSED TO ANY PT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTRUMENT MANAGER SOFTWARE JOP CALCULATOR/DATA PROCESSING MODULE JQP DATA INNOVATIONS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *