MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-25 for 05278406001 790-4324 manufactured by Ventana Medical Systems Inc.
[76014193]
It is unknown if there is a deterioration in patient health. We have asked the customer multiple times with no response. Investigation statement and conclusion: there is no indication of a malfunction of ventana medical system's instrument or assay. No corrections taken by the manufacturer since no ventana product malfunction identified. However information was provided to the customer on the "impact of environmental stress on various histology slide types". The customer has now changed from histobond slides to another slide manufacturer (tomo slides from matsunami). They have reported no issues since switching slide types. This is an initial and final report.
Patient Sequence No: 1, Text Type: N, H10
[76014196]
Customer used a same slide positive control tissue section which stained positive. Patient sample was negative and accordingly patient was diagnosed triple negative (er, pr, her2). Six weeks later, the patient sample was re-stained in another hospital and found to be er-positive. They assumed the reason for the failed staining in the first run was the slide surface properties on the slides they used. The customer has now changed from histobond slides to another slide manufacturer (tomo slides from matsunami).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2017-00002 |
| MDR Report Key | 6592947 |
| Date Received | 2017-05-25 |
| Date of Report | 2017-05-25 |
| Date of Event | 2017-01-19 |
| Date Mfgr Received | 2017-04-25 |
| Date Added to Maude | 2017-05-25 |
| 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 | NA TIM GIBLIN |
| Manufacturer Street | 1910 EAST INNOVATION PARK DR NA |
| Manufacturer City | TUCSON 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 |
| Generic Name | CONFIRM ER |
| Product Code | NQN |
| Date Received | 2017-05-25 |
| Model Number | 05278406001 |
| Catalog Number | 790-4324 |
| Lot Number | ASKU |
| ID Number | UDI #04015630972241 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-05-25 |