MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-11-01 for PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY 790-2991 manufactured by Ventana Medical Systems, Inc..
[21401429]
The pathway anti-her-2/neu (4b5) rabbit monoclonal primary antibody reagent dispenser is not available for evaluation as it was completely used by the customer and discarded. The reagent dispenser was used on multiple slides and all stained appropriately with the exception of the slide reported as false negative. This slide was not a type recommended in the current package insert for the product. That labeling recommends the use of superfrost plus slides or equivalent. The apes superfrost slides used by the originating hospital are not positively charged and had been treated in-house. Ventana has been unable to obtain any information on how nobles hospital treats their specimen slides pre-analytically. To date there is no evidence that a malfunction of a ventana product caused or contributed to the false negative result reported. The investigation into the issue is continuing and a follow-up report will be sent if new information is obtained.
Patient Sequence No: 1, Text Type: N, H10
[21415567]
A customer from (b)(6) complained about a false negative her-2 result (using the ventana pathway anti-her-2/neu (4b5) rabbit monoclonal primary antibody and the ventana benchmark ultra stainer module) that led to misdiagnosis and change in patient treatment (herceptin treatment was stopped). (b)(6) hospital sent patient slides to (b)(6) hospital to be stained using pathway her-2 on the benchmark ultra instrument (run date (b)(6) 2012). The patient material was liver biopsy, which showed metastatic tumor. This patient had a her-2 positive (3+) breast tumor. (b)(6) hospital sent the patient sample on a superfrost slide (not superfrost plus as is recommended in the product package insert) that was treated in-house ((b)(6)). There was no separate positive control tissue on same slide. (b)(6) hospital ran a ventana pathway her-2 4-in-1 control slide in the same day serving as the positive control. The her-2 negative result was reported (b)(6) 2012 back to (b)(6) hospital, which lead to removal of herceptin treatment from the patient. The patient requested that the test be repeated. (b)(6) hospital sent the patient sample to another site and the result was her-2 positive (3+). (b)(6) hospital informed (b)(6) hospital of the discrepancy on (b)(6) 2012 and a re-test was performed that same day on a spare slide that resulted in a positive her-2 result. A ventana pathway her-2 4-in-1 control slide in the same run served as the positive control slide in that re-test run.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2012-00005 |
| MDR Report Key | 2816000 |
| Report Source | 01,05,06 |
| Date Received | 2012-11-01 |
| Date of Report | 2012-10-03 |
| Date of Event | 2012-08-22 |
| Date Mfgr Received | 2012-10-03 |
| Date Added to Maude | 2012-11-02 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ROBERT BROOKS |
| Manufacturer Street | 1910 E. INNOVATION PARK DR. |
| Manufacturer City | TUCSON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5208777191 |
| Manufacturer G1 | VENTANA MEDICAL SYSTEMS, INC. |
| Manufacturer Street | 1910 E. INNOVATION PARK DR. |
| Manufacturer City | TUCSON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85755 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY |
| Generic Name | SYSTEM, TEST, HER-2/NEU,IHC |
| Product Code | MVC |
| Date Received | 2012-11-01 |
| Catalog Number | 790-2991 |
| Lot Number | B10865 |
| Device Expiration Date | 2013-07-03 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTANA MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 1910 E. INNOVATION PARK DR. TUCSON AZ 85755 US 85755 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-01 |