MAUDE Adverse Event Report: INTELERAD MEDICAL SYSTEMS INCORPORATED INTELEPACS; PICTURE ARCHIVING AND COMMUNICATION SYSTEM

Model Number INTELEVIEWER 4-10-1 AND EARLIER VERSIONS

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Problem description: following a client complaint, intelerad has identified a software problem in the image fusion module which may display an incorrect calculation of standard uptake value (suv) when loading the presentation state of image for a previously calculated (and saved) region of interest (roi).This problem could lead radiologists to base their diagnosis/report on incorrect anatomical measurements leading to incorrect medical treatment.No patient incident has been reported at this moment - this problem is documented as a precaution.Investigation details: one customer complaint ((b)(4)) bug identified: (b)(4).This is a bug due to a missing coordinate transformation, which manifests itself only when the ct axial spacing is not 1mm.Most if not all of our testing data to that point had been from ge which had 1mm spacing, so this bug was not seen, until we had a pet/mr dataset with axial spacing not equal to 1mm.Even then, the bug as stated was that the max pixel was not in the cubical voi region.We did not note that the max pixel was incorrect for the given region.The bug only applies to restored presentation states; any modification of a voi read from presentation states causes max suv to be calculated correctly the incorrect max suv is that of an adjacent region, so is random, and more than likely not to correspond to the actual region of interest, therefore the error should be noticeable.The displayed suv at the cursor location is correct, contradicting the incorrect max suv.The "go to max" associated with the voi will triangulate out of the voi box, indicating that something is wrong.All of the max suvs in the presentation states will be incorrect as above, increasing the likelihood that the error will be noticed the fix ((b)(4)) is available in inteleviewer 4-11-1 and later versions.The investigation was conducted on the client's systems and was reproduced on intelerad's systems (inteleviewer version 4-101-1-p180).Assessment of risk to user: description of hazardous situation in use of the device: incorrect calculation of suv when loading presentation state of image for a previously calculated (and saved) roi.This may lead to incorrect diagnosis.This problem is currently documented as a known risk: risk #2.3 in risk management summary (eng-007 issue 21).The mitigation in place reduces the risk for the general case of suv measurements, but not for datasets such as the one that caused the incident, nor the specific use case of displaying a measurement when reloading a presentation state.The risk can be further reduced through additional design factors taking into account specific datasets and the case of reloading the presentation state.Probability of risk: before mitigation: occasional (3).After mitigation: remote (2).Severity of risk: before mitigation: injury requiring treatment (3) (in the worst case).After mitigation: injury requiring treatment (3) (in the worst case).Detectability (user awareness.If device failure occurs, is it easily recognized by user): the reported incorrect suv is more or less random, so does not correspond to the associated volume.Detectability increases with the number of measurements, since the lack of correspondence between incorrect values and associated volumes becomes more obvious.Can be recognized in the normal case by trained users.Risk vs.Benefit comparison (to help determine the recall strategy and type of the recall): reloading a saved presentation state is a basic function of the device.The risk is small compared to the benefit as it is a significant time saver, and normally reduces the risk or errors of repeating measurements by hands.How often does the problem occur? how often can the problem cause direct or indirect harm to the patient? only caused by data where the axial spacing is not 1mm.It may cause harm if it goes undetected, and there is a major discrepancy between the real value and what is displayed, and there is no other means to confirm the diagnosis before the patient is treated.The device has been in use for two years with only a single reported incident, with no indication of real harm.Describe the factors that may contribute to product risk to the patient problem occurs for patient high/low resolution ct or mr scans where axial resolution is != 1, and where patient measurements are stored for later reload.Factors that may contribute to product risk (i.E.Device design, manufacturing problems, or use error): as above.Risk assessment summary: function: display previously saved suv measurement.Failure mode/defect: incorrect suv displayed.Local effect: incorrect measurement, leading to incorrect diagnosis if undetected.System effect: none.Adverse health consequences: incorrect diagnosis leading to incorrect treatment if undetected, resulting in harm from incorrect treatment or missing/delayed treatment.Severity: 3 injury requiring treatment.Probability: 3 occasional.Risk rating: medium.Corrective action: removing the affected version will prevent users from encountering the problem.Proposed recall action: intelerad will: identify all clients affected, i.E.All clients with access to the image fusion module of intelepacs - 31 august 2016.Inform all concerned clients of the issue (recall letter) - 31 august 2016.Provide all clients that do not already have a fixed version of the device with a software update - 30 september 2016.Estimated completion date of the proposed recall action is end of september 2016.

• Brand Name: INTELEPACS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATION SYSTEM
• Manufacturer (Section D): INTELERAD MEDICAL SYSTEMS INCORPORATED; 895 de la gauchetiere west; suite 400; montreal, quebec H3B 4 G1; CA H3B 4G1
• Manufacturer (Section G): INTELERAD MEDICAL SYSTEMS INCORPORATED; 895, de la gauchetière west; suite 400; montreal, quebec H3B 4 G1; CA H3B 4G1
• Manufacturer Contact: luce caron ; 895, de la gauchetiere west,; suite 400; montreal, quebec H3B 4-G1 ; CA H3B 4G1 ; 9316222
• MDR Report Key: 5851400
• MDR Text Key: 51473364
• Report Number: 9615916-2016-00002
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INTELEVIEWER 4-10-1 AND EARLIER VERSIONS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1