inforMED
MalfunctionMUJ

PINNACLE 18.0

Received Aug 24, 2022 · Event occurred Aug 15, 2022

Report 3004022368-2022-00005 · MDR key 15285745

Device

Generic name

System, Planning, Radiation Therapy Treatment

Model number

PINNACLE 18.0

Catalog number

870237

Product problems

  • Program or Algorithm Execution Failure
  • Program or Algorithm Execution Failure

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

MANUFACTURING INVESTIGATION CURRENTLY UNDERWAY. NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: COMPLAINT: (B)(4). DATE OF REPORT 20220823.

Description of Event or Problem

THE DOSE FILE THAT WAS EXPORTED TO MIM AND TO MOBIUS FOR 3 PATIENT PLANS IS SHOWING A CALCULATED DOSE VALUE THAT IS DIFFERENT FROM WHAT IS IN PINNACLE 18.0.1. THIS BEHAVIOR WAS IDENTIFIED AT A CUSTOMER SITE AFTER THEY TRANSFERRED MULTIPLE PATIENT PLANS TO MOBIUS FOR PLAN QA PURPOSES. THE PLANS FAILED QA IN MOBIUS. UPON FURTHER INVESTIGATION THE USER DISCOVERED THAT THE DOSE INFORMATION EXPORTED OUT OF PINNACLE DID NOT MATCH THE DOSE IN THE PLANS IN PINNACLE. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION BY THE MANUFACTURER.

Additional Manufacturer Narrative

MANUFACTURER¿S INVESTIGATION HAS IDENTIFIED A SPECIFIC CODING ISSUE THAT WAS INTRODUCED IN THE DEVELOPMENT PHASE OF PINNACLE SOFTWARE VERSION 16.4.2 AS THE ROOT CAUSE OF THIS ISSUE. THIS CODING ISSUE HAS BEEN CORRECTED AND THIS FIX IS BEING DISTRIBUTED TO THE CUSTOMER VIA INSTALLATION OF A SERVICE PACK, SPECIFICALLY IN THIS CASE, 18.0.1 SERVICE PACK 1. INTERNAL CROSS REFERENCE: COMPLAINT PR# (B)(4). DATE OF REPORT 2022/09/16.

Description of Event or Problem

THE DOSE FILE THAT WAS EXPORTED TO MIM AND TO MOBIUS FOR 3 PATIENT PLANS IS SHOWING A CALCULATED DOSE VALUE THAT IS DIFFERENT FROM WHAT IS IN PINNACLE 18.0.1. THIS BEHAVIOR WAS IDENTIFIED AT A CUSTOMER SITE AFTER THEY TRANSFERRED MULTIPLE PATIENT PLANS TO MOBIUS FOR PLAN QA PURPOSES. THE PLANS FAILED QA IN MOBIUS. UPON FURTHER INVESTIGATION THE USER DISCOVERED THAT THE DOSE INFORMATION EXPORTED OUT OF PINNACLE DID NOT MATCH THE DOSE IN THE PLANS IN PINNACLE.