BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICON P/G3

    MDR report key: 268404 · Received March 10, 2000

    Report

    Report Number
    1423253-2000-00008
    Event Type
    Other
    Date Received
    March 10, 2000
    Date of Event
    February 11, 2000
    Report Date
    March 9, 2000
    Manufacturer
    SIEMENS MEDICAL SYSTEMS
    Product Code
    JWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN CREATING COMPOSITE FILE TO USE FOR THE CARDIAC REVIEW PROGRAM WITH A SELECTION OF REST/STRESS, THE DATASETS ARE MISLABELED ON THE COMPOSITE PAGE OF THE CARDIAC REVIEW PROGRAM. PT WAS MISDIAGNOSED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON P/G3 NUCLEAR MEDICINE COMPUTER JWM SIEMENS MEDICAL SYSTEMS 5249177 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other