MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2013-10-21 for OMNYX IDP SOFTWARE MEDIA BUNDLE VERSION 1.1 DPS S/W VERSION 1.1 OMN-10005056-1 manufactured by Omnyx Llc.
[17155378]
A customer reported that one of the annotation tools contained within the dps 1. 1 software appeared to miscalculate the area of a region of interest on a scanned slide. Internal investigation confirmed that the annotation tools used within the dps version 1. 1 image viewer will display incorrect measurements and area calculations for a region of interest on a scanned slide, under certain use conditions.
Patient Sequence No: 1, Text Type: D, B5
[17362567]
Eval summary: issue summary - a customer reported that one of the annotation tools contained within the dps 1. 1 software appeared to miscalculate the area of a region of interest on a scanned slide. Eval - investigation at out company confirmed that the annotation tools used within the dps version 1. 1 image viewer will display incorrect measurements and area calculations for a region of interest on a scanned slide, under certain use conditions. Source code review identified where this error was introduced into dps 1. 1. Customer was instructed not to use any area calculations displayed by the viewer annotation tools including all shapes and the linear measurement tool until a solution could be identified. Corrective action - customer were notified of a field corrective action on or about (b)(4) 2013 and were instructed to 1) discontinue use of the measurement and area calculation features of the annotation tools (line, rectangle/square, ellipse/circle, and freeform) in the dps image viewer; 2) verify measurements and calculations on glass slides, if any of the tools have been used for measurements or area calculations on clinical cases; and 3) notify any other users of the software at their site of this issue. A new version (1. 2) of dps software is currently under development. Engineering is reviewing and revising test cases to ensure appropriate test case coverage prior to executing formal verification testing. Customers will be provided with an updated version of the software when it becomes available. This correction was reported to the fda (b)(4) district office on (b)(4) 2013 as medical device correction and removal report number 3008491142-10/15/13-001-c.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008491142-2013-00001 |
| MDR Report Key | 3535999 |
| Report Source | 01,05,08 |
| Date Received | 2013-10-21 |
| Date of Report | 2013-10-18 |
| Date of Event | 2013-09-20 |
| Date Mfgr Received | 2013-09-23 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-01-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID SMITH |
| Manufacturer Street | 1251 WATERFRONT PLACE |
| Manufacturer City | PITTSBURGH PA 15222 |
| Manufacturer Country | US |
| Manufacturer Postal | 15222 |
| Manufacturer Phone | 4128943911 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 3008491142-10/15/13-001- |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNYX IDP SOFTWARE MEDIA BUNDLE VERSION 1.1 |
| Generic Name | DIGITAL PATHOLOGY SOFTWARE |
| Product Code | OEO |
| Date Received | 2013-10-21 |
| Model Number | DPS S/W VERSION 1.1 |
| Catalog Number | OMN-10005056-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OMNYX LLC |
| Manufacturer Address | 1251 WATERFRONT PLACE PITTSBURGH PA 15222 US 15222 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-21 |