MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-23 for STRATIFY JCV DXSELECT ASSAY EL1950 manufactured by Focus Diagnostics, Inc..
[5326401]
This pt has been diagnosed with multiple sclerosis (ms) and was doing on ms drug tysabri manufactured by biogen idec. This pt was tested for jcv on (b)(4) 2013 by focus ref lab and obtained (b)(6) results, which lead to the decision of taking the pt off from tysabri since jcv (b)(6) patients are at risk of death if continuing tysabri treatment. In (b)(6) 2014, same pt was retested for jcv and results were (b)(6). The pt's ms condition has worsened to the point that he is permanently disabled possibly as a result of taken off the ms drug tysabri. Doctor made contact with biogen for advise in (b)(6) 2014. In (b)(6) 2014, doctor contacted biogen again and biogen contacted focus diagnostics in (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
[12774930]
(b)(4). Method, results, conclusions: other - because the original kit involved in the misdiagnosis in (b)(6) 2013 can't be returned for investigation, and focus' investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023365-2015-00001 |
| MDR Report Key | 4476041 |
| Report Source | 05 |
| Date Received | 2015-01-23 |
| Date of Report | 2015-01-13 |
| Date of Event | 2015-01-13 |
| Date Mfgr Received | 2015-01-13 |
| Device Manufacturer Date | 2012-11-05 |
| Date Added to Maude | 2015-02-03 |
| 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 | VALERIE CIMMARUSTI, CLS |
| Manufacturer Street | 11331 VALLEY VIEW ST |
| Manufacturer City | CYPRESS CA 90630 |
| Manufacturer Country | US |
| Manufacturer Postal | 90630 |
| Manufacturer Phone | 5622406484 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATIFY JCV DXSELECT ASSAY |
| Generic Name | ANTI-JCV ANITBODY DETECTION ASSAY |
| Product Code | OYP |
| Date Received | 2015-01-23 |
| Model Number | EL1950 |
| Catalog Number | EL1950 |
| Lot Number | X122564 |
| Device Expiration Date | 2013-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOCUS DIAGNOSTICS, INC. |
| Manufacturer Address | 10703 PROGRESS WAY CYPRESS CA 90630 US 90630 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-01-23 |