BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE

    MDR report key: 237654 · Received August 27, 1999

    Report

    Report Number
    2916556-1999-00150
    Event Type
    Injury
    Date Received
    August 27, 1999
    Date of Event
    February 27, 1998
    Report Date
    February 27, 1998
    Manufacturer
    ADAC LABORATORIES
    Product Code
    IYY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE M.D. RELIED UPON THE VANTAGE ATTENUATION CORRECTION DATA, AND AS A CONSEQUENCE, MISDIAGNOSED A PATIENT. THE PATIENT UNNECESSARILY RECEIVED CARDIAC CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANTAGE NUCLEAR MEDICINE EQUIPMENT IYY ADAC LABORATORIES 9200-0411D-END NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization