MAUDE Adverse Event Report: TOPCON CORPORATION IMAGENET 6; SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC

Medical Device Problem Codes	Computer Software Problem (1112); Program or Algorithm Execution Problem (4033)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Soon after we received the information from topcon europe medical on dec.21, 2018, we determined the software described in the hospital's "adverse incident report" was imagenet 6 and started the investigation to find the bug.Investigation result; as the request and response with imagenet 6 are not synchronizing, if a data processing process is busy, then the responses can be made in random order.In such case, if a data processing process is enough busy, then a mismatch between displayed patient identification data and displayed thumbnails of patient images can be occurred.This defect bug existed in the imagenet 6 from initial release version.When i patient is selected in the patient data and if other patient is selected prior to the display of the primary patient's thumbnails is completed, then the primary patient's thumbnails are displayed with secondary patient's identification information such as name, patient's id, etc.On the monitor screen of the pc used.This defect state can occur all versions of imagenet 6 that have been released in the field.We stopped shipment of imagenet 6 from manufacturer in (b)(4), warehouse in (b)(4), topcon's subsidiaries all over the world and daughter companies of these subsidiaries on dec.28, 2018.The corrected version of the imagenet 6 will released from the manufacturer in (b)(4) on jan 16, 2018.Field safety corrective actions are still in planning.
Event or Problem Description
On dec 21, 2018, we topcon corporation received an "adverse incident report" that was submitted from a hospital in (b)(6) to (b)(6) regarding our product imagenet 6 from topcon europe medical (our subsidiary in (b)(4), our mdd representative).They noticed that (b)(6) required to submit a manufacturer's incident report to them within 30 days on dec 20, 2018 to them.In the hospital's "adverse incident report" following was described as the incident.Diagnostic oct scan viewing software has a bug that can display the scans of a previous patient under the name and details of the following patient.This has the potential to significantly harm patients as decisions may be made on the incorrect scans being displayed.Such scans are used to determine if a patient requires intravitreal injections of drugs into the eye to prevent blindness due to macular degeneration and other conditions.Topcon informed on the 23rd october 2018.Recently updated software.Problem identified as persisting on the 17th december 2018.Such software will be it use in multiple eye departments in the (b)(6) and overseas.

• Brand Name: IMAGENET 6
• Common Device Name: SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC
• Manufacturer (Section D): TOPCON CORPORATION; 75-1; hasunuma-cho; itabashi-ku, tokyo 174-8 580; JA 174-8580
• MDR Report Key: 8258530
• Report Number: 9614661-2019-00001
• Device Sequence Number: 16748641
• Product Code: NFJ
• UDI-Device Identifier: 04562123288582
• UDI-Public: 04562123288582
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial

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
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/28/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other