MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2013-09-05 for COBAS TAQSCREEN WNV (WEST NILE VIRUS) TEST 04741722190 manufactured by Roche Molecular Systems.
[15026422]
Roche molecular systems was recently made aware of an allegation in a published article of a patient who died after receiving an apheresis plasma unit from a donor who tested non-reactive in individual pools for the cobas taqscreen wnv (west nile virus) test. When this donor was included in a pool of 6 originally, it tested as reactive but all 6 of the individual pools were non-reactive when the frozen plasma was later retested, 4 out of 5 units were reactive. The article was published in "morbidity and mortality weekly report", aug 9, 2013, entitled 'fatal west nile infection after probable transfusion-associate transmission - colorado, 2012.? Below are excerpts from the article: "in august 2012, a man with non-hodgkin? S lymphoma was admitted to hospital for chemotherapy and autologous stem cell transplant. ... He died on hospital day 47. Postmortem evaluation showed diffuse encephalitis. Wnv igm antibodies were identified in serum collected on hospital day 43. Wnv rna was detected by taqman reverse transcription-pcr (rt-pcr) on brain and spinal cord tissues collected at autopsy. The patient had received allogenic, leukoreduced, irradiated blood products during hospital days 13-30, including 6 units of red blood cells, 2 units of platelets, and 2 units of fresh frozen plasma. He received 2 additional units each of red blood cells and platelets on day 44. One apheresis donor was positive for wnv igm antibodies and for wnv neutralizing antibodies by plaque reduction neutralization testing performed on serum collected 56 days after the implicated donation. The apheresis platelet unit was donated on the recipient? S hospital day 9 and transfused on day 14. The implicated donation was initially screened as part of a minipool with five other donations; the mp-nat was reactive using the cobas taqscreen west nile virus test (roche molecular systems). However, all of the units comprising the minipool were nonreactive when tested by id-nat using the same assay and were released into the blood supply per fda guidance at the time of the investigation. The quarantined unit of fresh frozen plasma was retrieved and tested for wnv. Freshly thawed aliquots from this unit were reactive for wnv on four of five replicate cobas taqscreen west nile virus tests, but wnv rna could not be detected by conventional taqman rt-pcr. An aliquot from the same plasma unit, tested 58 days after being thawed and stored at 39. 2? F (4. 0? C) was nonreactive by the procleix wnv nat assay (gen-probe incorporated). The unit was positive for wnv igm antibodies by microsphere-based immunosorbent assay, wnv immunoglobulin g antibodies by enzyme-linked immunosorbent assay, and wnv neutralizing antibodies by plaque reduction neutralization testing. " in the article's "reported by" section, roche customer "bonfils blood center" denver is listed, with a contact of tuan n. Le, md. The original customer never contacted roche when the incident occurred , and did not file a complaint. Attempts to contact the customer and all stakeholders for this customer to determine if additional information may be available have been unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
[15417307]
Date of event - exact date is unknown, although it did occur in (b)(6) 2012. Elisa, antibody west nile virus was chosen as the closest available product code. However, the cobas taqscreen west nile virus (wnv) test is a nucleic acid amplification and detection test. Publication - article was published in "morbidity and mortality weekly report", aug 9, 2013, entitled "'fatal west nile infection after probable transfusion-associate transmission - colorado, 2012". Attempts to contact the customer and all stakeholders for this customer to determine if additional information may be available have been unsuccessful. Information regarding testing interval and storage conditions is currently unknown. West nile virus can deteriorate and an initial positive can become negative upon retesting, as less amplifiable virus will be available, falling below the limit of detection (lod) of the test. It is possible that the donor had a low level viremia that could not be consistently identified by either minipool or individual donation testing. This cannot be conclusively determined based on the available information. The assessment from roche molecular systems medical & scientific affairs is: the probable transfusion-associated transmission does not represent an rmd product malfunction. Most likely, the asymptomatic donor of the implicated platelet unit had waning wnv viremia, and, hence, levels of wnv rna below the limit of detection of the cobas taqscreen wnv test. At very low levels of viremia, nucleic acid tests (nat assays) performed on minipools or individual units can demonstrate test-to-test variability, as seen in this case. Severely immunocompromised individuals, such as the transfusion recipient in this case, are particularly vulnerable to infection, even at low levels of viremia and in the presence of presumptively-protective wnv-specific antibodies. (b)(4). Unable to contact customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2013-00026 |
| MDR Report Key | 3327049 |
| Report Source | 03 |
| Date Received | 2013-09-05 |
| Date of Report | 2013-08-08 |
| Date Mfgr Received | 2013-08-08 |
| Date Added to Maude | 2013-09-05 |
| 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 | VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202S |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS TAQSCREEN WNV (WEST NILE VIRUS) TEST |
| Generic Name | NUCLEIC ACID WEST NILE VIRUS TEST |
| Product Code | NOP |
| Date Received | 2013-09-05 |
| Catalog Number | 04741722190 |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HW 202S BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2013-09-05 |