BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELEPACS

    MDR report key: 3832004 · Received March 7, 2014

    Report

    Report Number
    9615916-2014-00001
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    INTELERAD MEDICAL SYSTEMS INCORPORATED
    Product Code
    LLZ
    PMA / PMN Number
    K083520
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTION PLAN: IMMEDIATELY CONTACT AFFECTED CLIENTS BY E-MAIL TO NOTIFY THEM OF THE PROBLEM (STARTED). THE TOTAL SUM OF AFFECTED CLIENTS IS VERY LIMITED AND WELL KNOWN. ONLY ONE CLIENT IN THE USA MAY BE AFFECTED. REMOTELY TURN OFF THE CONFIGURATION SETTING THAT PREVENTS THE "LESS THAN" CHARACTER TO BE DISPLAYED IN THE INTELEVIEWER PT RECORD TAB (ALREADY COMPLETED AT SOME CLIENT SITES). DEPLOY SOFTWARE UPDATE WHEN AVAILABLE AT AFFECTED SITES WITH CLIENTS' PERMISSION. SAVE MANUFACTURER-CLIENT INTERACTIONS IN OUR TICKETING SYSTEM TO RECORD ACTIVITIES AND FOLLOW-UP (ON-GOING).

    Description of Event or Problem · 1

    WE HAVE BEEN MADE AWARE OF A PROBLEM WITH THE CONFIGURATION OF OUR SOFTWARE BY A CLIENT IN (B)(6). NO PT WAS REPORTED IMPACTED BY THE PROBLEM. THIS REPORT IS THEREFORE SUBMITTED PREVENTIVELY. ONLY WHEN INTELEPACS IS INTERFACED WITH A RIS THAT USES HTML FORMATTING TO FORCE THE FONT COLOR OF THE REPORT TO A DARK COLOR (LIKE BLACK), WILL BE REPORTED VIEWED WITHIN INTELEVIEWER NOT DISPLAY "<" CHARACTERS. FOR EXAMPLE, UNDER THOSE CONDITIONS, A REPORT WITH THE TEXT "<1.5CM WOULD BE DISPLAYED AS "1.5CM". A REPORT WHICH DOES NOT DISPLAY THE "<" CHARACTER MAY GIVE MISLEADING CLINICAL INFO TO RADIOLOGISTS AND REFERRING PHYSICIANS. ANALYSIS OF THE PROBLEM REVEALED THAT THE DATA STORED IN THE PACS DATABASE ACCURATELY REFLECTS THE CONTENT TRANSMITTED BY THE RIS (I.E., "<" CHARACTERS ARE PRESENT IN THE TEXT). THE PROBLEM ONLY ARISES IN THE INTELEVIEWER APPLICATION AT THE TIME WHEN REPORT TEXT IS FORMATTED FOR DISPLAY, AND IF THE PREFERENCE KEY "OVERRIDE CLIENT REPORT COLORS" IS SET TO TRUE. THE 'OVERRIDE CLIENT REPORT COLORS' CONFIGURATION WAS CREATED TO ACCOMMODATE RIS SYSTEMS THAT USE HTML FORMATTING TO FORCE THE FONT COLOR OF THE REPORT TO A DARK COLOR BUT DO NOT FORCE THE BACKGROUND COLOR TO A LIGHT COLOR. INTELEVIEWER DISPLAYS REPORTS WITH LIGHT TEXT ON A DARK BACKGROUND AND THEREFORE THE PREFERENCE IS TO OVERRIDE THE DARK TEXT COLOR AND MAKE IT LIGHT SO THAT IT IS VISIBLE ON A DARK BACKGROUND. A BUG IN THE FILTER FOR THE DARK TEXT FORMATTING CAUSED "<" CHARACTERS TO ALSO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138597 INTELEPACS PICTURE ARCH & COMM SYSTEM LLZ INTELERAD MEDICAL SYSTEMS INCORPORATED IV VERSION 381 P355 NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1