MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for IMAGENET 6 manufactured by Topcon Corporation.
[134887915]
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.
Patient Sequence No: 1, Text Type: N, H10
[134887916]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614661-2019-00001 |
| MDR Report Key | 8258530 |
| Date Received | 2019-01-17 |
| Date of Event | 2018-10-21 |
| Date Facility Aware | 2018-12-28 |
| Date Mfgr Received | 2018-12-21 |
| Date Added to Maude | 2019-01-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TAKAO SUGAWARA |
| Manufacturer Street | 75-1 HASUNUMA-CHO |
| Manufacturer City | ITABASHI-KU, TOKYO 174-8580 |
| Manufacturer Country | JA |
| Manufacturer Postal | 174-8580 |
| Manufacturer G1 | TOPCON YAMAGATA CO., LTD |
| Manufacturer Street | 574 AZA ISHIDA OAZA URUSHIYAMA |
| Manufacturer City | YAMAGATA-SHI, YAMAGATA-KEN 990-2196 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 990-2196 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IMAGENET 6 |
| Generic Name | SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC |
| Product Code | NFJ |
| Date Received | 2019-01-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOPCON CORPORATION |
| Manufacturer Address | 75-1 HASUNUMA-CHO ITABASHI-KU, TOKYO 174-8580 JA 174-8580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-17 |