MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-08 for VIRTUOSO SOFTWARE V5.5 V55-01-PS 07299303001 manufactured by Ventana Medical Systems, Inc..
[28181266]
We were recently made aware of a virtuoso software product issue that could potentially impact patient safety for customers using version 5. 4 or 5. 5. The software scans slides at 4x,10x, 20x, or 40x magnifications. For images scanned at 4x, 10x, and 40x magnification, the linear and area measurement tools display a value that is 1/5,? And 2x the actual measurement, respectively. The measurement will be displayed incorrectly regardless of what magnification you are viewing the image at. For images that are scanned at 20x magnification, the measurement tools work properly in all versions of virtuoso including versions 5. 4 and 5. 5. For customers in the eu/eea and canada who use virtuoso v5. 4 and v5. 5 for primary diagnosis, the measurement tools for slides that were scanned at 4x, 10x, or 40x, could potentially cause incorrect estimation of clinical stage leading to improper treatment. Most pathology labs scan at 20x magnification, which is not impacted by this error. Use of the measurement tool in the virtuoso software is considered 'primary digital diagnosis', which is not on-label in the united states. Therefore, us-based laboratories should perform validation of the measurement tool prior to use of the software for clinical cases.
Patient Sequence No: 1, Text Type: N, H10
[28181267]
Customer from (b)(6) reported when using software to select the same area in 2 bif pictures scanned at 20x and 40x respectively, the size of the scanned tissue as reported by the software are different, depending on scan magnification: at 40x the size value is double the real size. Clinical evaluation regarding changes in therapeutic management for up to 18 patients has not been provided; however early information specifies changes in t or n staging, leading to variations in assessing prognosis. Microscopic tumor measurements are most directly tied to patient staging and therapeutic intervention in the diagnosis of melanoma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2015-00003 |
| MDR Report Key | 5136210 |
| Date Received | 2015-10-08 |
| Date of Report | 2015-09-10 |
| Date of Event | 2015-07-20 |
| Date Mfgr Received | 2015-09-10 |
| Device Manufacturer Date | 2014-07-18 |
| Date Added to Maude | 2015-10-08 |
| 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 TIM GIBLIN |
| Manufacturer Street | 1910 E INNOVATION PARK DR. |
| Manufacturer City | TUCSON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5208777035 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VIRTUOSO SOFTWARE V5.5 |
| Generic Name | MICROSCOPE, AUTOMATED, IMAGE ANALYSIS, OPERATOR INTERVENTION |
| Product Code | NOT |
| Date Received | 2015-10-08 |
| Model Number | V55-01-PS |
| Catalog Number | 07299303001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTANA MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 1910 E INNOVATION PARK DRIVE TUCSON AZ 85755 US 85755 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-08 |