MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-28 for COBAS TAQSCREEN MPX TEST, V2 US-IVD 05969484190 manufactured by Roche Molecular Systems, Inc.
[37729953]
The investigation is 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
[37729954]
A blood center in the us filed a complaint alleging generation of a (b)(6) for one donor while using the cobas taqscreen mpx test v2, lot w07772. The donor tested (b)(6) with the cobas ampliscreen test. The donor was (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[44734014]
A us customer reported the generation of a (b)(6) result for a donor sample when tested with the cobas taqscreen mpx test, v2. The donor generated positive serology results and a reactive result with another pcr test. Review of the pcr growth curve for the sample in question indicated that it was anomalous in nature. This type of growth curve has not been reported nor identified previously. Sufficient sample volume is not available for further investigation. Without the sample, the cause for the anomalous growth curve cannot be determined, and the sequence of the sample cannot be obtained and evaluated against the cobas taqscreen mpx test, v2 performance claims. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2016-00009 |
| MDR Report Key | 5396450 |
| Date Received | 2016-01-28 |
| Date of Report | 2016-05-09 |
| Date of Event | 2015-12-17 |
| Date Mfgr Received | 2015-12-30 |
| Date Added to Maude | 2016-01-28 |
| 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 | NA VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Manufacturer G1 | NA |
| Manufacturer Street | NA NA |
| Manufacturer City | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS TAQSCREEN MPX TEST, V2 US-IVD |
| Generic Name | ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA |
| Product Code | MZP |
| Date Received | 2016-01-28 |
| Model Number | NA |
| Catalog Number | 05969484190 |
| Lot Number | W07772 |
| ID Number | NA |
| Device Expiration Date | 2017-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 088763733 US 088763733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-28 |