INGENUITY TF PET/MR

Description of Event or Problem

WITH THE INFO PROVIDED, THE CUSTOMER REPORTED THAT AFTER PERFORMING A CLINICAL PET/MR BRAIN SCAN, THE 256X256 (2MM) AND THE 576X576 (4MM) ATTENUATION MAPS (MU-MAP) DATA WAS MISALIGNED. THE 4MM ATTENUATION MAP WAS SHIFTED TO THE LEFT AND UP ABOUT 1 VOXEL (2 TO 4 MM). THIS RESULTED IN THE RECONSTRUCTIONS TO HAVE A LEFT TO RIGHT DIFFERENCE (PROFILE RAMP) IN PET ACTIVITY CONCENTRATION AND SUV VALVE. THE CLINICAL PRODUCT SPECIALIST STATED THAT THERE HAS BEEN NO REPORT OF HARM OR IMAGE MISINTERPRETATION TO A PT AS A RESULT OF THIS ISSUE.

Additional Manufacturer Narrative

(B)(4). INITIAL MDR MAILED ON APRIL 14, 2015. ON (B)(6) 2015, THE CUSTOMER REPORTED THAT AFTER PERFORMING A CLINICAL PET/MR BRAIN SCAN, THE 256X256 (2MM) AND THE 576X576 (4MM) ATTENUATION MAPS (MU-MAP) DATA WAS MISALIGNED. THE 4MM ATTENUATION MAP WAS SHIFTED TO THE LEFT AND UP ABOUT 1 VOXEL (2 TO 4 MM). THIS RESULTED IN THE RECONSTRUCTIONS TO HAVE A LEFT TO RIGHT DIFFERENCE (PROFILE RAMP) IN PET ACTIVITY CONCENTRATION AND SUV VALUE. THE CLINICAL PRODUCT SPECIALIST STATED THAT THERE HAS BEEN NO REPORT OF HARM OR IMAGE MISINTERPRETATION TO A PATIENT AS A RESULT OF THIS ISSUE. FURTHER REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER HAS DETERMINED THAT THE VARIANCE IS WITHIN THE ACCEPTABLE TOLERANCE AS DEFINED IN THE FOLLOWING MITIGATION: GEMSRS4158: AFTER SOFTWARE CALIBRATION, THE MAXIMUM ERROR BETWEEN THE POSITION OF A POINT IN THE MR SLICE AND THE POSITION OF THE CORRESPONDING POINT IN THE PET FIELD OF VIEW SHALL BE LESS THAN 4 MM. THE OBSERVED VARIANCE WAS WITHIN THE 4MM TOLERANCE AND THEREFORE NO CORRECTION WAS APPLICABLE FOR THIS ISSUE. NO FURTHER CAUSE DETERMINATION IS APPLICABLE BECAUSE FURTHER INVESTIGATION OF THE INFORMATION PROVIDED BY THE CUSTOMER HAS DETERMINED THAT THE VARIANCE IS WITHIN THE ACCEPTABLE TOLERANCE AS DEFINED IN GEMSRS4158: AFTER SOFTWARE CALIBRATION, THE MAXIMUM ERROR BETWEEN THE POSITION OF A POINT IN THE MR SLICE AND THE POSITION OF THE CORRESPONDING POINT IN THE PET FIELD OF VIEW SHALL BE LESS THAN 4 MM.

Description of Event or Problem

WITH THE INFORMATION PROVIDED, THE CUSTOMER REPORTED THAT AFTER PERFORMING A CLINICAL PET/MR BRAIN SCAN, THE 256X256 (2MM) AND THE 576X576 (4MM) ATTENUATION MAPS (MU-MAP) DATA WAS MISALIGNED. THE 4MM ATTENUATION MAP WAS SHIFTED TO THE LEFT AND UP ABOUT 1 VOXEL (2 TO 4 MM). THIS RESULTED IN THE RECONSTRUCTIONS TO HAVE A LEFT TO RIGHT DIFFERENCE (PROFILE RAMP) IN PET ACTIVITY CONCENTRATION AND SUV VALUE. THE CLINICAL PRODUCT SPECIALIST STATED THAT THERE HAS BEEN NO REPORT OF HARM OR IMAGE MISINTERPRETATION TO A PATIENT AS A RESULT OF THIS ISSUE.

Additional Manufacturer Narrative

(B)(4). WE WILL FILE A FOLLOW UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).