MAUDE Adverse Event Report: INTELERAD MEDICAL SYSTEMS INTELEPACS; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS

Model Number	INTELEPACS 4-11-1 AND UP
Medical Device Problem Codes	Device Displays Incorrect Message (2591); No Apparent Adverse Event (3189); Patient Data Problem (3197)
Health Effect - Clinical Code	Misdiagnosis (2159)
Type of Reportable Event	Malfunction
Event or Problem Description
Intelerad has identified a software problem in its (b)(6) software.The issue is triggered by the presence of the pipe character ( | ) in the report.If the text of an intelepacs-generated report contains an unquoted pipe character (i.E.|) then querying for it via hl7 will result in a report that appears to be truncated at that point.Only clients with versions 4-11-1 and later using multi method reporting or inteledictation as well as the hl7gatewayserver dynamic report renderer are affected.This issue could impact the patient safety because it can result in missing report text.While in some cases it may be obvious, in other cases it could result in lost addenda, which would not be visible to the health professional who could make a diagnosis with incomplete or missing data.Root cause analysis: root cause analysis: the dynamic report renderer of hl7gatewayserver application failed to escape a special character in a report, causing the hl7 observation field to be unexpectedly truncated when retrieving reports through hl7.This only affects reports stored in the report access api (i.E., mmr or inteledictation), where the client is using a dynamic report renderer.Affected software versions system is potentially affected if the version "r" identifier has a number below the following: pacs 4-11-1 r69, pacs 4-12-1 r81, pacs 4-14-1 r65, pacs 4-15-1 r47, pacs 4-16-1 r46, pacs 4-17-1 r21.Risk assessment: description of hazardous situation in use of the device: o when viewing a report, parts of the report text following the unescaped pipe character ( | ) are no longer displayed.O this problem is currently documented as a known risk.The mitigation in place to reduce this risk did not work to prevent risk to patient because it applied to a different class of report transformation.O this risk can be further reduced by ensuring that any character escaping for serialization is performed closer to the persistence layer in a generic way that applies independently of configuration.O the probability of risk before mitigation is remote because the mis-rendering must have clinical significance and the absence of the affected text must not be evident to exhibit the behavior.O the severity of risk before mitigation is potential misdiagnosis leading to possible injury requiring treatment o the detectability of this problem being easily recognized by user will depend on the positioning of the corruption within the text, it may not be readily detectable by a trained user.Risk vs.Benefit comparison (to help determine the recall strategy and type of the recall) o benefit of an increase in average time savings, diagnostic accuracy, data integrity and image accessibility outweighs the risk of low probability events leading to incorrect diagnosis.Main factors for this problem to occur is the usage of special characters in report text.Function: report display failure mode/defect: report characters missing local effect: misleading display of report text system effect: none adverse health consequences: potential misdiagnosis severity: delay in treatment (1 out of 5) probability: remote (2 out of 5) risk rating: low corrective action : intelerad will inform all clients whose system has the affected software versions (4-11-1 and up).Intelerad will install a software update on all clients' systems with the affected software versions, in the following sequence: i.Sites whose system meets the described conditions above (i.E.Inteledictation and multi-method reporting) - only on site in uk has the configuration causing this problem.Ii.Sites whose system currently do not have the conditions described above.Intelerad will provide a list of potentially affected reports to the clients whose systems meet the described conditions.Intelerad will create tickets in its service portal to track and to schedule the software upgrade required for each client system.Corrective action calendar: correction of the software: estimated end of (b)(6) 2019.Software update of clients systems whose systems have the configuration causing the problem: (b)(6) 2019.Software update of clients systems whose systems do not have the configuration causing the problem: end of (b)(6) 2019.

• Brand Name: INTELEPACS
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS
• Manufacturer (Section D): INTELERAD MEDICAL SYSTEMS; 800, boul. de maisonneuve e.; 12th floor; montreal, quebec H2L 4 L8; CA H2L 4L8
• MDR Report Key: 8566453
• Report Number: 9615916-2019-00001
• Device Sequence Number: 2090973
• Product Code: LLZ
• UDI-Device Identifier: B228INTELEPACS0
• UDI-Public: B228INTELEPACS0
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: INTELEPACS 4-11-1 AND UP
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1