BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT PATH

    MDR report key: 670132 · Received January 26, 2006

    Report

    Report Number
    1058332-2006-00002
    Event Type
    Malfunction
    Date Received
    January 26, 2006
    Report Date
    December 6, 2001
    Manufacturer
    SCC SOFT COMPUTER
    Product Code
    LNX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CLIENT HAD MADE A DECISION TO USE THE SOFTPATH MODULE IN A NONSTANDARD MANNER. THE CLIENT'S STANDARD METHOD OF OPERATION IS TO REGISTER AND PROCESS A CASE FOR THE CG ACCESSION BASE AND THEN SIGN OUT THE CASE WITHOUT ENTERING ANY TYPE OF RESULTS. THEREFORE A FINAL REPORT HAS NO DIANGOSIS TEXT. LATER THE CLIENT CREATED A SUPPLEMENTAL REPORT TO ISSUE DIAGNOSTIC INFO. IMMEDIATELY AFTER CREATING THIS REPORT THE USER ACCESSES THE "CREATE NEW" SELECTION IN THIS OPTION FOR ANOTHER CASE. THE SYSTEM THEN CREATED A "FINAL" DOCUMENT FOR THE CURRENT CASE AND THE TEXT FROM THE PREVIOUSLY PRINTED CASE FOR ANOTHER PT IS SAVED FOR THIS PT. THIS ANOMALY OCCURS FOR TWO REASONS: 1. THE "FINAL REPORT" WAS NOT CREATED AS THE SYSTEM EXPECTED. 2. THE TEMPORARY DIRECTORY THAT IS CREATED DURING THE "PRINT PENDING" OPERATION IS NOT CLEARED UNTIL EXITING TO THE MAIN MENU. SUBSEQUENTLY THE PT RECEIVED AN ADT UPDATE TRANSACTION AND THIS EVENT TRIGGERED A RE-TRANSMITTAL OF REPORTS FROM SOFTPATH RESULT REPORTING INTERFACE. THE INCORRECT FINAL REPORT IS TRANSMITTED TO THE HIS AT THAT TIME AND THAT LEAD TO THE COMPLAINT OF THIS DESCRIBED SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT PATH LAB INFO SYSTEM LNX SCC SOFT COMPUTER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *