BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTMIC(GUI)

    MDR report key: 920299 · Received September 17, 2007

    Report

    Report Number
    920299
    Event Type
    Malfunction
    Date Received
    September 17, 2007
    Date of Event
    April 28, 2007
    Report Date
    September 17, 2007
    Manufacturer
    SOFT COMPUTER CONSULTANTS, INC.
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    LABORATORY INFORMATION SYSTEM - SOFTLABMIC 4.0.1 (BUILD 14:5)SOFT COMPUTER CONSULTANT LABORATORY INFORMATION SYSTEM LOADED COMPREHENSIVE PATCH 4.0.1 BUILD 14:5 THIS PAST SPRING. SINCE THEN SOFTMIC RESULT ENTRY LOST AN IMPORTANT FEATURE THAT ALERTS TECHNOLOGIST WHEN SOMEONE ELSE IS IN THE SAME PATIENT DATABASE. PREVIOUS TO THE COMPREHENSIVE PATCH, THERE WAS A PROPERLY FUNCTIONING WARNING MESSAGE THAT WOULD ALERT THE TECHNOLOGIST WHEN SOMEONE ELSE WAS USING THE SAME PATIENT DATABASE. WITHOUT THIS WARNING MESSAGE, THE FOLLOWING PATIENT RESULT ENTRY COULD POTENTIALLY NOT BE SAVED. THIS IS A USER DEFINABLE FUNCTION THAT COULD LEAD TO THE LOSS OF PATIENT DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTMIC(GUI) SOFTWARE, LABORATORY INFORMATION LNX SOFT COMPUTER CONSULTANTS, INC. SOFTLABMIC 4.0.1 BUILD 14:5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *