MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-15 for BENCHMARK ULTRA 05342716001 750-600 manufactured by Ventana Medical Systems Inc.
[86418605]
The case indicates that while performing pathway her-2 (4b5) testing on a benchmark ultra instrument a patient sample stained negative (on (b)(6) 2017) with appropriate staining of the same slide control tissue. The control tissue was placed towards the top of the slide and the patient sample below that. For unknown reasons, the patient was subsequently tested based on other test types (oncotype and fish) at a 3rd party location and was reported as her2 positive (results received on (b)(6) 2017). The customer then performed another her2 (4b5) test for this patient (on (b)(6) 2017) and the results were positive. The patient sample was also er+/pr+ which are additional markers which are typically run in the panel of tests. The impact to patient care has been asked, but is unknown at this time, which is the reason for filing this mdr. Other negative slides from the same day were repeated with no other discordant results. No other issues were noted for pathway her-2 (4b5) antibody which, along with appropriate staining of the control tissue on the affected slide, suggests that the antibody performed as intended. The root cause for a sporadic false negative staining event, while other tests on the run performed appropriately, is unknown. An initial evaluation of the instrument found a component out of specification. However, after bringing the rtd instrument into specification the customer continues to experience the issue intermittently. Also, during on-site troubleshooting of this issue, the customer encountered a slide on a subsequent run where the control tissue (now placed at bottom of slide) failed to stain as intended with a different antibody (tdt not 4b5). This is suggestive of a slide surface hydrophobicity issue.
Patient Sequence No: 1, Text Type: N, H10
[86418606]
False negative pathway her-2 (4b5) staining on a patient sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2017-00004 |
| MDR Report Key | 6870968 |
| Date Received | 2017-09-15 |
| Date of Report | 2017-09-15 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-08-18 |
| Date Added to Maude | 2017-09-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA TIM GIBLIN |
| Manufacturer Street | 1910 EAST INNOVATION PARK DR NA |
| Manufacturer City | TUSCON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5208777035 |
| Manufacturer G1 | VENTANA MEDICAL SYSTEMS INC |
| Manufacturer Street | 1910 E INNOVATION PARK DR NONE |
| Manufacturer City | TUCSON AZ 857551962 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 857551962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BENCHMARK ULTRA |
| Generic Name | ULTRA |
| Product Code | MYA |
| Date Received | 2017-09-15 |
| Model Number | 05342716001 |
| Catalog Number | 750-600 |
| Lot Number | NA |
| ID Number | UDI# 04015630981052 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| 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 DR NA TUCSON AZ 857551962 US 857551962 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-15 |