BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASYS

    MDR report key: 285663 · Received July 12, 2000

    Report

    Report Number
    2916556-2000-00299
    Event Type
    Malfunction
    Date Received
    July 12, 2000
    Date of Event
    April 17, 2000
    Report Date
    June 28, 2000
    Manufacturer
    ADAC LABORATORIES
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    AUTOQUANT DOES NOT ALWAYS NORMALIZE DATA TO THE MYOCARDIUM. THIS MAY PRODUCE A FALSE POSITIVE TEST RESULT. NO INJURIES HAVE BEEN REPORTED AS A RESULT OF THIS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEGASYS NUCLEAR MEDICINE EQUIPMENT KPS ADAC LABORATORIES 2157-3001A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN