MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-01-14 for 780-4422 05586640001 manufactured by Ventana Medical Systems, Inc.
[36031330]
Evaluation of the customer run reports indicate that correct staining, using the same product (inform her2 dual ish dna probe cocktail), lot d11446 was observed on slides run simultaneously as the suspect slides.
Patient Sequence No: 1, Text Type: N, H10
[36031331]
Customer alleges ventana's assay produced a false positive result resulting in herceptin treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2016-00001 |
| MDR Report Key | 5369068 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-01-14 |
| Date of Report | 2016-01-14 |
| Date of Event | 2015-03-12 |
| Date Mfgr Received | 2015-12-15 |
| Date Added to Maude | 2016-01-14 |
| 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 E 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 85755 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85755 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | HER2 DUAL ISH |
| Product Code | NYQ |
| Date Received | 2016-01-14 |
| Model Number | 780-4422 |
| Catalog Number | 05586640001 |
| Lot Number | D11446 |
| ID Number | UDI #04015630970155 |
| Device Expiration Date | 2015-08-28 |
| 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 DRIVE 1910 E INNOVATION PARK DRIVE TUCSON AZ 857551962 US 857551962 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-14 |