MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-06-28 for COBAS TAQSCREEN MPX TEST 04584244190 manufactured by Roche Molecular Systems.
[2119837]
A customer site in (b)(4) reported that a patient sample generated a (b)(6) test result, for (b)(6), when tested with the cobas taqscreen mpx test. Specifically, the customer reported that the donor specimen was serology (b)(6) and generated non-reactive test results with the cobas taqscreen mpx test. The patient sample was tested for serology multiple times with the architect (abbott) and murex (diasorin) tests.
Patient Sequence No: 1, Text Type: D, B5
[9198983]
A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing. The outcome of the investigation will be communicated through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9402463]
Device evaluated by manufacturer: yes. Result: device performed according to specifications conclusion: no failure detected and product within specification. The customer reported that they obtained a non-reactive (b)(6) result from a donor with the cobas taqscreen mpx test but the donor specimen was serology (b)(6). The donation was blocked from the blood supply. The customer returned 3 aliquots of the donor sample which were then tested with the cobas ampliprep / cobas taqman (cap/ctm) hiv-1 v2. 0 test, which generated a result of target not detected (tnd). This indicates that the samples did not contain an (b)(6) above the limit of detection (lod) of the cap/ctm hiv-1 v2. 0 test of (b)(6). Sequencing analysis did not find (b)(6) sequences. Therefore, it cannot be determined if mismatches to the assay oligos account for the non-reactive results generated by the cobas taqscreen mpx test. In addition, this does not necessarily mean that there is no (b)(6) present in these samples, as the lack of viral sequence information could be due to sequence heterogeneity under the primers used for sequencing and / or due to low viral titers. Based on the above information, no product non-conformance was identified. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2011-00061 |
| MDR Report Key | 2142084 |
| Report Source | 01,05 |
| Date Received | 2011-06-28 |
| Date of Report | 2011-08-30 |
| Date of Event | 2011-05-03 |
| Date Mfgr Received | 2011-05-31 |
| Date Added to Maude | 2012-05-11 |
| 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 MPX TEST |
| Generic Name | HEPATITIS VIRAL B DNA DETECTION |
| Product Code | MKT |
| Date Received | 2011-06-28 |
| Catalog Number | 04584244190 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2011-06-28 |