MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-27 for CONFIRM ANTI-ER (SP1) PRIMARY ANTIBODY 05278414001 790-4325 manufactured by Ventana Medical Systems, Inc..
[4326758]
Laboratory customer reported an allegation of a false negative diagnostic result with the use of our estrogen receptor (er) tissue diagnostic assay. The original test was conducted in (b)(6) 2013 and resulted in a negative er diagnosis. The pt required a recession in (b)(6) 2014 and testing at that time indicated a positive er diagnosis.
Patient Sequence No: 1, Text Type: D, B5
[11905667]
The customer has discarded the implicated kit. Labeling, including troubleshooting and precautions, continues to be correct. The kit was used in other pt cases and reportedly performed as claimed. There is no feedback from the customer as to confirmatory tests they may have performed on the pt in (b)(6), or in regard to current status of the pt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028492-2014-00001 |
| MDR Report Key | 3733075 |
| Report Source | 05 |
| Date Received | 2014-03-27 |
| Date of Report | 2014-03-27 |
| Date of Event | 2013-06-14 |
| Date Mfgr Received | 2014-03-06 |
| Device Manufacturer Date | 2012-09-25 |
| Date Added to Maude | 2014-04-09 |
| 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 Street | 1910 EAST INNOVATION PARK DR. |
| Manufacturer City | TUCSON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5208777239 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONFIRM ANTI-ER (SP1) PRIMARY ANTIBODY |
| Generic Name | ESTROGEN RECEPTOR PRIMARY ANTIBODY |
| Product Code | MYA |
| Date Received | 2014-03-27 |
| Model Number | 05278414001 |
| Catalog Number | 790-4325 |
| Lot Number | C08379 |
| ID Number | NA |
| Device Expiration Date | 2014-03-10 |
| 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 | 1. Other | 2014-03-27 |