BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT PATCH

    MDR report key: 670101 · Received January 26, 2006

    Report

    Report Number
    1058332-2006-00004
    Event Type
    Malfunction
    Date Received
    January 26, 2006
    Report Date
    September 17, 2004
    Manufacturer
    SCC SOFT COMPUTER
    Product Code
    LNX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TEXT FROM ONE CASE IS OVERWRITING ANOTHER. CASE RSC-24027 WAS ENTERED AND SAVED AND THEN CASE RSC-23945 WAS ENTERED AND SAVED. LATER REVIEW OF THE DOCUMENT OF 23945 REVEALED THAT THE TEXT WAS OVERWRITTEN BY CASE 24027. REVIEW OF THE SOFTWARE FAILURE REVEALED THAT THE TEMPORARY DIRECTORY WAS NOT CLEARED BEFORE PROCESSING EACH SUBSEQUENT CASE DURING ONE SESSION OF RESULTS ENTRY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *