MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-11 for 05269806001 760-500 manufactured by Ventana Medical Systems Inc.
[108492875]
Same slide controls were not used at this site. Use of same slide controls would have prevented this issue.
Patient Sequence No: 1, Text Type: N, H10
[108492876]
Gastric her2 (b)(6) 2017 scored 0, repeated (b)(6) 2018 and scored 2+. Fish test performed and reported as positive on (b)(6) 2018. Due to being a case from (b)(6), the patient will certainly receive treatment following this result and a delay is likely to have been caused because of retesting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2018-00009 |
| MDR Report Key | 7509024 |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-11 |
| Date of Event | 2018-03-08 |
| Date Mfgr Received | 2018-04-12 |
| Date Added to Maude | 2018-05-11 |
| 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 | TUSCON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5208777035 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | DAB |
| Product Code | LDT |
| Date Received | 2018-05-11 |
| Model Number | 05269806001 |
| Catalog Number | 760-500 |
| Lot Number | NA |
| ID Number | UDI 04015630972173 |
| Operator | HEALTH 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 | 2018-05-11 |