MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-05-06 for COBAS TAQSCREEN MPX TEST 04584244190 manufactured by Roche Molecular Systems.
[17183181]
(b)(4). The (b)(6) from the donation tested on (b)(6) 2010 cannot be determined, as there is no remaining plasma available for investigation. The ct values of the original and re-test results are indicative of a low-titer sample that is below the limit of detection (lod) of the cobas taqscreen mpx test. Therefore, reproducibility of (b)(6) results for this donation, which appears to be below lod, is expected to be less than 95%, as stated in the package insert for the test. Local investigation of the most recent donation from this donor ((b)(6) 2011) yielded (b)(6) using the (b)(4). The donor is suspected of having an (b)(6), which is characterized by low level, fluctuating (b)(6) dna levels in the plasma and, for this reason, (b)(6) dna is usually not consistently detected, even with individual testing. No product non-conformance was identified. The issue of (b)(6) results is possible, when the (b)(6) is at or below lod. In that case, >5% of sample replicates are expected to be negative, and this information is documented in product labeling. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[17192777]
A customer in (b)(6) reported that an alleged (b)(6) test result with the cobas taqscreen mpx test lead to the transfusion of (b)(6) donor material. The donor was originally tested with the cobas taqscreen mpx test on (b)(6) 2010. The test result from this donation was (b)(6) in a pool of 6. On (b)(6) 2011, the same donor was tested, in a pool of 6, with the cobas taqscreen mpx test. The test result from this donor was (b)(6). Additionally, the donation was (b)(6). Subsequent resolution testing and further discriminatory testing (cobas ampliscreen test) yielded (b)(6) results. The customer then tested, in a pool of 6 and a pool of 1, the donor's archived sample from the (b)(6) 2010 donation with the cobas taqscreen mpx test with id. The test results were (b)(6). Using cobas ampliscreen the (b)(6) result were (b)(6) in a pool of 6 and a pool of 1. Three recipients have received blood components from the (b)(6) 2010 donation. The recipients are (b)(6). Two of the three recipients have the record of (b)(6) before transfusion
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2011-00051 |
| MDR Report Key | 2079571 |
| Report Source | 01,05 |
| Date Received | 2011-05-06 |
| Date of Report | 2011-04-11 |
| Date of Event | 2011-04-07 |
| Date Mfgr Received | 2011-04-11 |
| Device Manufacturer Date | 2009-12-22 |
| Date Added to Maude | 2011-05-06 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS TAQSCREEN MPX TEST |
| Generic Name | HEPATITIS VIRAL B DNA DETECTION |
| Product Code | MKT |
| Date Received | 2011-05-06 |
| Catalog Number | 04584244190 |
| Lot Number | M12236 |
| Device Expiration Date | 2010-09-30 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-05-06 |