INGENUITY TF PET/MR

Description of Event or Problem

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.

Additional Manufacturer Narrative

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).