BEUDAMED
    FDA Adverse Event Summary report: N

    INGENUITY TF PET/MR

    MDR report key: 3525443 · Received December 11, 2013

    Report

    Report Number
    1525965-2013-00440
    Date Received
    December 11, 2013
    Report Date
    November 25, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    OUO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEFT TO RIGHT MISALIGNMENT WITH PET RECONSTRUCTED IMAGES. THE IMAGES APPEAR DIAGNOSTIC AND SHOW A FINDING THAT IS TYPICAL WITH PATIENTS WITH MEMORY DISORDER. AFTER RECONSTRUCTING DATA AGAIN, THE FINDING DISAPPEARS. THEREFORE, THE INITIAL RECONSTRUCTION HAS LEFT TO FALSE POSITIVE RESULTS IN MORE THAN ONE PATIENT. THE ISSUE WAS DISCOVERED DURING A RESEARCH PROTOCOL, WHEN THE SCANNING OF HEALTHY VOLUNTEERS PRESENTED WITH THE SAME FINDINGS AS THOSE PATIENTS WITH KNOWN MEMORY DISORDERS. THE HEALTHY VOLUNTEERS HAVE UNDERGONE A SERIES OF NEUROPSYCHOLOGICAL TESTS AND HAVE BEEN DETERMINED HEALTHY. THE DISCREPANCY BETWEEN THE IMAGING FINDINGS AND NEUROPSYCHOLOGICAL RESULTS HAS LED TO FURTHER INVESTIGATION AND THE SITE IS CURRENTLY REVIEWING PATIENT DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648231 INGENUITY TF PET/MR OUO PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 882380

    Patients

    Seq Age Sex Outcome Treatment
    1