BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVEAL XL

    MDR report key: 552414 · Received April 19, 2004

    Report

    Report Number
    1034973-2004-00001
    Event Type
    Other
    Date Received
    April 19, 2004
    Date of Event
    February 11, 2004
    Report Date
    March 17, 2004
    Manufacturer
    CTI PET SYSTEMS, INC.
    Product Code
    KPS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE END USER PERFORMED A 3D NORMALIZATION ON THE PET SCANNER. WHEN PROMPTED FOR THE CE-68 PHANTOM, THE END USER SELECTED 2D INSTEAD OF 3D. THIS AFFECTED THE STANDARD UPTAKE VALUES (SUV) OF 39 PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVEAL XL POSITRON EMISSION TOMOGRAPHY (PET) SCANNER KPS CTI PET SYSTEMS, INC. 3600211-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN