BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRO

    MDR report key: 442184 · Received February 6, 2003

    Report

    Report Number
    2916556-2003-00002
    Event Type
    Malfunction
    Date Received
    February 6, 2003
    Date of Event
    January 8, 2003
    Report Date
    February 6, 2003
    Manufacturer
    UGM MEDICAL SYSTEMS, INC.
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN THE EVENT THAT A TECHNOLOGIST MAKES AN ERROR DURING DEMOGRAPHIC INPUT, PERFORMS THE STUDY AND SUBSEQUENTLY MODIFIES THE PT INFO AFTER THE EXAM, THE DATABASE ON THE PET SCANNER SHOWS THE CORRECTED INFO. HOWEVER, THE STUDIES THAT ARE SENT OUT TO A RECEIVING SYSTEM MAY NOT HAVE THE CORRECTED INFO. THIS ISSUE WAS FOUND DURING SYSTEM ACCEPTANCE TESTING WITH A PACS SYSTEM AT THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRO POSITRON EMISSION TOMOGRAPHY KPS UGM MEDICAL SYSTEMS, INC. 5000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *