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 2013-03-13 for PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY 790-2991 manufactured by Ventana Medical Systems, Inc..
[3381707]
A customer site in italy reported that a new pathologist that recently joined the hospital staff had reviewed the site's breast cancer screening cases for her-2 results and questioned the number of 0/1+/2+ cases (compared to available literature). The site decided to review all cases from 2012 to present and set aside suspect cases depending on the her-2 slide/other breast panel marker results/hematoxylin and eosin slide results/patient history for re-evaluation. The pathologist wanted to be sure that any cases originally scored as negative were correct. Of all the patient slides reviewed in this retrospective analysis, one case that was originally scored as 0 for her-2 has been scored as 2+ upon retest. This 2+ immuohistochemistry result has also been confirmed as amplified her-2 positive using in-situ hybridization as a confirmatory test. The site used ventana pathway anti-her-2/neu (4b5) rabbit monoclonal primary antibody to test the patient tissue for her-2 expression. The intended use for the product follows:this antibody is intended for in vitro diagnostic use. Ventana medical systems, inc. 's (ventana) pathway anti-her-2/neu (4b5) rabbit monoclonal primary antibody (pathway her2 (4b5)) is a rabbit monoclonal antibody intended for laboratory use for the semi-quantitative detection of her2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic tissue on a ventana automated immunohistochemistry slide staining device. It is indicated as an aid in the assessment of breast cancer patients for whom herceptin treatment is considered. The investigation conducted to date has resulted in a determination that this site in italy was using a staining protocol that was not completely consistent with the protocol defined in the current package insert for the product. The customer was using a cell conditioning step (antigen unmasking) of 8 mins. This protocol was being run on a ventana benchmark ultra stainer module. The recommended time for cell conditioning for the her-2 4b5 assay is 36 mins. This decrease in cell conditioning time would explain why an original result may have stained weakly due to inadequate antigen retrieval. Positive controls at this site have stained appropriately and retests of patient tissue using the same ventana product with the recommneded protocol stained appropriately indicating no malfunction of product performance.
Patient Sequence No: 1, Text Type: D, B5
[10542316]
There was no malfunction of a ventana product associated with the incident reported. A protocol used by the user facility included a cell conditioning time that is inadequate to ensure appropriate antigen retrieval is accomplished. When the patient tissue was retested with the ventana product using the recommended protocol the tissue in question returned a positive result. It should be noted that other samples that originally produced negative results for her-2 at this user facility also remained negative upon retesting. However, the short cell conditioning time used in the user facility staining protocol created a potential for false negative results for tissue that was low expressing for her-2. There was no need to evaluate the product as control tissues and retests stained appropriately as did high expressing her-2 tissue even with the low cell conditioning time. The information related to the current health of the patient affected by the original negative her-2 result is that the patient is being treated with chemotherapy (fluor-uracil, epirubicine e cyclophosphamide). As of the date of this submission, ventana does not have information about whether this patient would have been started on herceptin therapy in addition to the chemotherapy regimine. The customer site has corrected their protocol within the recommended parameters of the package insert.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028492-2013-00001 |
| MDR Report Key | 3002990 |
| Report Source | 01,05,06 |
| Date Received | 2013-03-13 |
| Date of Report | 2013-02-13 |
| Date of Event | 2013-01-15 |
| Date Mfgr Received | 2013-02-13 |
| Date Added to Maude | 2013-03-14 |
| 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 | 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 |
| 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 | 2013-03-13 |
| Model Number | NA |
| Catalog Number | 790-2991 |
| Lot Number | C03664 |
| ID Number | NA |
| Device Expiration Date | 2013-10-11 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2013-03-13 |