MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-06-20 for COBAS TAQSCREEN MPX TEST 04584244190 manufactured by Roche Molecular Systems.
[10038969]
(b)(4). No product or batch non-conformance was identified. Upon investigation there was no trend found in the field. Qc release data for 077859 was reviewed and the issue of discrepant results has not been observed. There have not been any manufacturing non-conformance reports for batch 077859. Retain testing of the complaint batch 077859 was tested for this case and generated valid and acceptable results. The sample was sent for sequencing analysis and despite several attempts to obtain a (b)(4) sequence from the sample, no virus sequence was obtained. -note: the sequencing analysis may detect a viral sequence with sample that has a viral load below (b)(4) copies/ml, thus if sample is thought to contain a (b)(4) low titer, sequencing analysis may not generate a (b)(4) sequence. Testing with the cobas taqman (b)(4) test for use with the high pure system generated a result of (b)(6) for both aliquots of the sample tested. A result of (b)(6) indicates that the calculated iu/ml are below the limit of detection of the assay. Report results as (b)(4) dna detected, less than (b)(6) iu/ml. According to the cobas taqman (b)(4) test for use with the high pure system package insert. The sample was individually tested with the cobas taqscreen mpx test, v2. 0 (mpx v2. 0) and generated (b)(6) results. The limit of detection for (b)(6) with the mpx v2. 0 test is (b)(6) iu/ml ((b)(4) average lod); therefore, it is possible that the sample with a low (b)(4) titer may not be detected by the assay 100% of the time. The results generated for the donor sample at the customer site, at (b)(4), and during the case investigation indicate that the sample contains a very low (b)(4) titer that through the poisson affect was sporadically detected with the mpx test at the customer site and with the chiron test at the (b)(4). This was further supported during the investigative testing as the cobas taqman (b)(4) test for use with the high pure system generated a result that indicates (b)(4) viral presence in the sample but at a very low titer (not quantifiable by the assay). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[15098513]
A customer in (b)(6) alleges that discrepant (b)(6) results were generated when using the cobas taqscreen mpx test. During a routine run with the mpx test a primary pool of 24 generated (b)(6) results. Six secondary pools of 4 were then tested and one pool generated a (b)(6) result. The donation was then tested in resolution pooling of 1 and generated negative results. The donation was then tested at (b)(6) using a competitor test (chiron). One donation was found to be not reactive (low level) and also generated (b)(6) negative serology results.
Patient Sequence No: 1, Text Type: D, B5
[15272918]
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
| Report Number | 2243471-2012-00027 |
| MDR Report Key | 2623238 |
| Report Source | 01,05 |
| Date Received | 2012-06-20 |
| Date of Report | 2012-09-13 |
| Date of Event | 2012-09-13 |
| Date Mfgr Received | 2012-09-13 |
| Date Added to Maude | 2012-10-12 |
| 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 | 2012-06-20 |
| Catalog Number | 04584244190 |
| Lot Number | 077859 |
| Device Expiration Date | 2013-09-30 |
| 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 BRANCHBUR NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-20 |