BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGFA IMPAX VERSION 5.2

    MDR report key: 1344857 · Received March 13, 2009

    Report

    Report Number
    2243528-2009-00001
    Event Type
    Injury
    Date Received
    March 13, 2009
    Date of Event
    July 27, 2007
    Report Date
    March 13, 2009
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K022292
    Removal / Correction Number
    N-0015-2007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT HAPPENED IN 2007, AND WAS REPORTED TO AGFA ON MARCH 2 OF 2009. AS A RESULT OF THE TIME DELAY FROM OCCURRENCE TO WHEN THIS WAS REPORTED TO AGFA, WE ARE UNABLE TO OBTAIN SOME OF THE INFORMATION THAT IS TYPICALLY AVAILABLE TO ASSIST US IN AN INVESTIGATION SUCH AS LOG FILES, MAP EVENTS, MONITOR LAYOUTS, CONFIGURATION, USER SETTINGS, ETC. FROM THE SITE IN QUESTION. THE IMPAX DESIGN ACCOMMODATES NUMEROUS WORKFLOWS THAT ARE TAILORED TO USERS' SPECIFIC PREFERENCES. IN THIS INTEGRATED DICTATION SETTING, THE IMPAX CLIENT WILL NOT ALLOW FOR A SECOND REPORT TO BE INITIATED. THERE ARE MULTIPLE VISUAL INDICATORS THAT INFORM THE USER OF WHAT STUDY IS BEING VIEWED, AND WHAT THE DICTATION STATUS IS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO US THAT IN 2007 A PATIENT WAS MISDIAGNOSED BECAUSE, THE RADIOLOGIST WAS LOOKING AT A STUDY FROM 2005, THINKING THAT THE STUDY WAS FROM 2007. A PATIENT AT THIS SITE HAS PRESENTED WITH WIDELY SPREAD METASTATIC DISEASE, WHICH ACCORDING TO A MEDICAL DOCTOR FROM THE SITE, MIGHT HAVE BEEN AVOIDED HAD THE PROPER STUDY BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGFA IMPAX VERSION 5.2 PICTURE ARCHIVING COMMUNICATION SYSTEM LLZ AGFA HEALTHCARE CORP. IMPAX 5.2

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other