MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-10-16 for HER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY 790-2991 manufactured by Ventana Medical Systems, Inc..
[20628105]
The customer contacted the ventana customer service center subsequent to receiving a medical device recall letter for lot #680957 pathway her2 (4b5). As a result of the recommendations in the recall, a review of their records showed that they had one (1) patient that required retesting, for which the results are still pending.
Patient Sequence No: 1, Text Type: D, B5
[20822533]
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. Light staining with lot #680957 is detectable if appropriate low-expressing/ low-level controls are utilized. Pathologists who are familiar with the usual appearance and intensity of their control tissues may recognize the problem as lighter then usual control tissue staining. 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 etc. ). Laboratories are instructed to use their own controls and pathologists are familiar with the performance of these controls in their laboratory. Investigation confirmed lot #680957 stained lighter when compared to other reference lots of pathway her2 (4b5). The light staining could result in scores of up to a full point reduction in the clinical score, which could prevent further evaluation and allow patients to go untreated. This issue of light staining is limited to lot #680957, and there have been no reported cases of patient diagnosis being adversely affected from this issue. Ventana medical system has notified all customer who have received lot #680957 and this lot has been recalled.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028492-2009-00002 |
| MDR Report Key | 1516913 |
| Report Source | 05,06 |
| Date Received | 2009-10-16 |
| Date of Report | 2009-09-17 |
| Date of Event | 2009-09-17 |
| Date Mfgr Received | 2009-09-17 |
| Device Manufacturer Date | 2009-07-01 |
| Date Added to Maude | 2010-01-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TWEED HANUSEK |
| Manufacturer Street | 1910 EAST INNOVATION PARK DR. |
| Manufacturer City | TUCSON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5202294130 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2028492-09/08/09-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY |
| Generic Name | PATHWAY HER2 (4B5) |
| Product Code | MVC |
| Date Received | 2009-10-16 |
| Model Number | 790-2991 |
| Catalog Number | 790-2991 |
| Lot Number | 680957 |
| ID Number | NA |
| Device Expiration Date | 2011-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTANA MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 1910 EAST INNOVATION PARK DR. TUCSON AZ 85755 US 85755 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-16 |