MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-08 for COBAS TAQSCREEN MPX TEST, V2.0, CE-IVD 05969492190 manufactured by Roche Molecular Systems.
[35800347]
The investigation into this issue is currently on-going. The outcome of this investigation will be communicated through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[35800348]
(b)(6) customer indicated that 3 donors were repeatedly generating (b)(6) serology results with multiple serology tests and (b)(6) pcr results with the cobas taqscreen mpx test, v2. 0, ce-ivd for use on the cobas s 201 system. As multiple cobas taqscreen mpx test, v2. 0 kit lots were used and generated consistent results, this mdr is not specific to any lot; rather, it is specific for the product in general. This mdr report (2243471-2016-00006) is specific to donor # 3.
Patient Sequence No: 1, Text Type: D, B5
[41233631]
A (b)(6) customer indicated that 3 donors were repeatedly generating (b)(6) results with multiple serology tests and (b)(6) results with the cobas taqscreen mpx test, v2. 0, ce-ivd for use on the cobas s 201 system. As multiple cobas taqscreen mpx test, v2. 0 kit lots were used and generated consistent results, this mdr is not specific to any lot; rather, it is specific for the product in general. This mdr report (2243471-2016-00006) is specific to (b)(6). On (b)(6)-2015, a new draw was obtained from the donor and run in pp1 with cobas taqscreen mpx test, v2. 0 kit, lot 193607 which again generated a (b)(6) result. These results are in agreement with the previous original (b)(6) results. The donation was additionally tested in (b)(6) using the cobas ampliprep / cobas taqman (cap/ctm) (b)(6) quantitative test, v2. 0 batch 173806 and generated (b)(6) results. This further rules out mutations in the target region of the mpx v2 test, as the cause of the (b)(6) results, as the cap/ctm (b)(6) v2 test is dual probe and generated a (b)(6) result. Based on the data provided and input from roche medical and (b)(6), the complaint issue is likely due to patients who are able to clear their (b)(6) infection, however, may remain (b)(6). Scientific literature on the subject states that about 20% of people clear the infection (but remain antibody positive) and, in donors, the percentage that are rna negative seems to be higher. Retain testing of the complaint kit batches 193607 and 185527 met specifications and did not reproduce the customer allegation. Based on this information, there is no indication of a product non-conformance and the cobas taqscreen mpx test, v2. 0 is performing as intended. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2016-00006 |
| MDR Report Key | 5354770 |
| Date Received | 2016-01-08 |
| Date of Report | 2016-03-25 |
| Date of Event | 2015-12-09 |
| Date Mfgr Received | 2015-12-09 |
| Date Added to Maude | 2016-01-08 |
| 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 | 3 |
| Event Location | 3 |
| 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, V2.0, CE-IVD |
| Generic Name | COBAS TAQSCREEN MPX TEST, V2.0 |
| Product Code | MZP |
| Date Received | 2016-01-08 |
| Catalog Number | 05969492190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 088763733 US 088763733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-08 |