BEUDAMED
    FDA Adverse Event Other Summary report: N

    VITREA2

    MDR report key: 450492 · Received March 18, 2003

    Report

    Report Number
    1933477-2003-00001
    Event Type
    Other
    Date Received
    March 18, 2003
    Date of Event
    March 3, 2003
    Report Date
    March 3, 2003
    Manufacturer
    VITAL IMAGES, INC.
    Product Code
    LNX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HOSPITAL TECHNICIAN HAD NOTICED THAT A FILM PRINTED FROM VITREA WAS LABELED WITH THE INCORRECT PATIENT NAME, THE TECHNICIAN NOTICED THE DISCREPANCY IN THE FILMS, DESTROYED THE INCORRECT FILMS AND REPRINTED NEW FILMS WITH THE CORRECT PATIENT NAME. THE SITE HAD RECENTLY BEEN UPGRADED FROM 2.6 TO 3.1 TO 3.2. THE INCIDENT OCCURRED AFTER THE 3.2 UPGRADE. AFTER ASCERTAINING THE DETAILS, IT WAS DETERMINED THAT THE HOSPITAL'S USE OF A GENERIC PATIENT ID (9999999) AT THE SCANNER, RESULTED IN ALL THE PATIENTS WITH THIS ID (A TOTAL OF THREE PATIENTS) TO BE GROUPED UNDER ONE NAME IN THE STUDY DIRECTORY. THEY HAVE THE CORRECT NAME IN GALLERY PAGE, BUT SOMETIMES HAD THE INCORRECT INFORMATION ON THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITREA2 3D RADIOLOGY VIEWER SOFTWARE LNX VITAL IMAGES, INC. VPMC-7299L *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other