Description of Event or Problem · 1
NO PATIENT INCIDENT REPORTED AT THIS MOMENT - THIS ISSUE IS DOCUMENTED AS A PRECAUTION. CONTEXT: INTELERAD HAS IDENTIFIED A SOFTWARE PROBLEM WITH THE MAGNIFICATION GLASS TOOL WHICH, IN SOME INSTANCES, DISPLAYS A DIFFERENT IMAGE THAN THE ONE CURRENTLY BEING SHOWN IN THE SELECTED VIEWPORT. IT APPEARS THAT THE TOOL IS DISPLAYING A MAGNIFIED IMAGE FOR A DIFFERENT SLICE OF THE SERIES. THIS COULD POTENTIALLY DELAY A DIAGNOSIS. THIS PROBLEM WAS REPORTED BY AN INTELERAD EMPLOYEE WHILE AT A CLIENT SITE. INVESTIGATION: (B)(4). THE SORTING ORDER OF AN IMAGE STACK IS NOT TAKEN INTO ACCOUNT BY THE MAGNIFICATION GLASS TOOL. IF THE USER IS USING REVERSE ORDERING (EITHER MANUALLY SELECTED OR THROUGH A PREFERENCE IN THE CASE OF TOMOSYNTHESIS) AND THEN USES THE MAGNIFICATION GLASS TOOL, THE IMAGE SHOWN IN THE TOOL WILL NOT BE THE ONE IN THE CURRENT VIEWPORT BUT RATHER THE CORRESPONDING POSITION FROM THE OPPOSITE END OF THE STACK. THIS DEFECT APPLIES TO ANY MODALITY WITH A STACK OF IMAGES, EX. TOMOSYNTHESIS, CT. THE DISCREPANCY IS HIGHLY DETECTABLE BY USER AND IS EXTREMELY UNLIKELY TO LEAD TO HARM TO THE PATIENT. DESCRIPTION OF HAZARDOUS SITUATION IN USE OF THE DEVICE: INCORRECT IMAGE BEING SHOWN WHILE USING THE MAGNIFICATION TOOL, WHICH COULD CAUSE A LOW POSSIBILITY OF DELAY IN TREATMENT. THE INCORRECT IMAGES DISPLAYED ARE HIGHLY EVIDENT TO RADIOLOGISTS. THIS PROBLEM IS NOT CURRENTLY DOCUMENTED AS A KNOWN RISK. A MITIGATION IS CURRENTLY IN PLACE TO REDUCE THIS RISK AND TO PREVENT RISK TO PATIENT. THE RISK CAN BE FURTHER REDUCED THROUGH ADDITIONAL INTERNAL SOFTWARE CHECKS TO PREVENT INCORRECT IMAGE DISPLAY WHEN INCONSISTENCIES ARE DETECTED. PROBABILITY OF RISK: REMOTE (2) SEVERITY OF RISK: IMPROBABLE (1) DETECTABILITY (USER AWARENESS. IF DEVICE FAILURE OCCURS, IS IT EASILY RECOGNIZED BY USER): HIGHLY DETECTABLE BY USER. RISK VS. BENEFIT COMPARISON: BENEFIT OF AN INCREASE IN AVERAGE TIME SAVINGS, DIAGNOSTIC ACCURACY, DATA INTEGRITY AND IMAGE ACCESSIBILITY OUTWEIGHS THE RISK OF LOW PROBABILITY EVENTS LEADING TO DELAYED DIAGNOSIS. THE PROBLEM IS ONLY CAUSED IN MULTI IMAGE SITUATIONS WHERE THE STACK ORDER IS REVERSED AND THE MAGNIFICATION GLASS TOOL IS USED. THE SOFTWARE FAILURE IS VERY EVIDENT AND EXTREMELY UNLIKELY TO LEAD TO HARM TO PATIENT. THE FEATURE HAS BEEN IN USE FOR EIGHT YEARS WITH ONLY A SINGLE REPORTED PROBLEM, WITH NO INDICATION OF REAL HARM. CORRECTIVE ACTIONS: INTELERAD WILL: 1) IDENTIFY ALL CLIENTS AFFECTED (19 SEPTEMBER 2017). 2) INFORM ALL CONCERNED CLIENTS OF THE ISSUE (SEPTEMBER 2017). 3) PROVIDE ALL CLIENTS WITH A SOFTWARE UPGRADE (INSTALLATION DATE AS AGREED WITH CLIENTS). ESTIMATED COMPLETION DATE OF THE PROPOSED RECALL ACTION IS JUNE 2018.