MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-06-04 for COBAS TAQSCREEN MPX TEST, CE-IVD 04584244190 manufactured by Roche Molecular Systems.
[3524852]
A customer site in the (b)(6) filed a complaint alleging that (b)(6) results were generated when using the cobas taqscreen mpx test. The donor sample was (b)(6) serology (b)(6). The blood collection was tested on (b)(6) 2013 and generated a (b)(6) result in pools of 6. The donor sample was tested in resolution testing pools of 1 on (b)(6) 2013 and generated an mpx (b)(6). The viral load was tested with the cobas ampliprep / cobas taqman hcv quant test and generated a titer of 18 iu/ml. The sample was retested with mpx in pools of 6 with 5 other (b)(6) donors on (b)(6) 2013 and generated an mpx (b)(6) result. Resolution testing of all 6 donors were all (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[10793339]
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. The associated us kit is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[34223752]
(b)(4). The customer alleged the generation of discrepant results for a donor sample with the cobas taqscreen mpx test in relation to serology and viral titer results. A sample collection from (b)(6) 2013 was (b)(6) with the cobas taqscreen mpx test (mpx test) during primary pools of 6 (pp6) testing. However, the sample collection was identified to be (b)(6) serology (b)(6) with a (b)(6) sample viral titer of 18 iu/ml. The sample collection was then further tested in primary pools of 1 and a mpx (b)(6) result was generated. During 24, (b)(6) 2013, repeat testing of the donor collection with 5 other (b)(6) donors in a pp6 generated a mpx (b)(6) result. However, upon resolution pooling of the (b)(6) pp6, all samples were found to be (b)(6). A previous collection for the same donor (collected in 2012) generated a (b)(6) mpx result during primary pools of 1 (pp1) testing. This result was concordant with the (b)(6) serology result obtained for the same donor sample. The donor samples were tested by roche using a viral load test: cobas ampliprep/cobas taqman hcv test, v2. 0. The collection from 2012 generated a target not detected result, which is in line with the (b)(6) mpx and (b)(6) serology results obtained for this collection. The collection from 2013 generated a titer of 15 iu/ml, which is line with the 18 iu/ml result obtained for this donor by the customer. A titer within the range of 15 to 18 iu/ml will not be detected by the mpx if tested in pools of 6 as this titer range falls below the average 95% limit of detection (lod) for the hcv target of 11 iu/ml. However, it may be detected in pools of 1. In this case, it is important to note that such a low titer samples falls within 95% lower and upper limit range of 7. 0 to 21. 7 iu/ml, respectively (as listed in the product labeling). This indicates that a titer within the limit range of 7. 0 to 21. 7 iu/ml may not be detected 100% of the time. Given that testing of the complaint kit lots are performing as expected, the result discrepancies observed by the customer are due to the donor sample itself. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2013-00014 |
| MDR Report Key | 3144347 |
| Report Source | 01,05 |
| Date Received | 2013-06-04 |
| Date of Report | 2013-08-08 |
| Date of Event | 2013-04-24 |
| Date Mfgr Received | 2013-08-08 |
| Date Added to Maude | 2013-08-23 |
| 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, CE-IVD |
| Generic Name | HEPATITIS VIRAL B DNA DETECTION |
| Product Code | MKT |
| Date Received | 2013-06-04 |
| Catalog Number | 04584244190 |
| Lot Number | 097314 |
| Device Expiration Date | 2014-04-30 |
| 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 BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-04 |