MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-03-20 for CONFIRM ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY 800-2996 manufactured by Ventana Medical Systems, Inc..
[17561655]
Confirm anti-her-2/neu (4b5) primary antibody - breast cancer pt (b)(6) sample false negative tissue diagnostic result reported to pt's physician. Pt missed herceptin treatment from late (b)(6) 2010 to (b)(6) 2011. Treatment has since resumed. Site reports no perceived health impact to pt. Complaint states that control slides showing staining issues were not caught before reporting to the doctor. Investigation shows no reagent or instrument malfunction by mfr. Pathway anti-her-2/neu (45b) rabbit monoclonal primary antibody catalog number 790-2991 is a similar product marketed in the usa under pma p990881.
Patient Sequence No: 1, Text Type: D, B5
[17710099]
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 pts for whom herceptin treatment is considered. Light or inconsistent staining with lot a00156 confirm, (use full name of the product) anti-her-2/neu (4b5) is detectable if appropriate controls are utilized. Non-staining in particular is an immediately evident indicator that stain run investigation is necessary. The test is designed to be read by a pathologist who has knowledge of proper interpretation of her2 scoring as well as the factors that can influence scores (i. E. Retrieval, tissue fixation, instrument variability, slide surface variability, etc. ). Laboratories are instructed to use their own controls and pathologists are familiar with the performance of these controls in their laboratory. The issue states that lot #a00156 confirm anti-her-2/neu (4b5) did not receive proper staining. There is lack of clarity if the required control slides were used, but improper staining was not caught or considered by the pathologist. Customer contacts have reported no adverse pt health effects specific to this erroneous reporting to physician. Investigation data show that the ventana reagent and instrumentation are functioning properly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028492-2011-00001 |
| MDR Report Key | 2507887 |
| Report Source | 05,06 |
| Date Received | 2012-03-20 |
| Date of Report | 2011-03-07 |
| Date of Event | 2011-02-04 |
| Date Mfgr Received | 2011-02-04 |
| Device Manufacturer Date | 2010-08-17 |
| Date Added to Maude | 2012-07-30 |
| 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 | RICHARD MOSS |
| Manufacturer Street | 1910 E. INNOVATION PARK DR. |
| Manufacturer City | TUCSON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5208777239 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Removal Correction Number | NONE |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONFIRM ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY |
| Generic Name | CONFIRM ANTI-HER-2/NEU (4B5) |
| Product Code | MVC |
| Date Received | 2012-03-20 |
| Model Number | 800-2996 |
| Catalog Number | 800-2996 |
| Lot Number | A00156 |
| ID Number | NA |
| Device Expiration Date | 2011-07-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. ORO VALLEY AZ 85755 US 85755 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-20 |