MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-15 for COBAS TAQSCREEN MPX TEST V2.0 CE-IVD 05969492190 manufactured by Roche Molecular Systems.
[36483968]
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
[36483971]
A blood bank in (b)(6) filed a complaint stating that (b)(6) results for one blood screening donor sample were generated when using the cobas taqscreen mpx v2. 0 ce-ivd test. The initial pool of one results were (b)(6). The repeat pool gave (b)(6). The final result was reported as (b)(6). All testing was performed on (b)(6) 2015. The serology results for this donor are currently unknown.
Patient Sequence No: 1, Text Type: D, B5
[37747494]
The customer from (b)(6) alleged discrepant hbv results for a donor when tested with the taqscreen mpx test, v2. 0. The patient's serology results were later found to be negative. The investigation determined that the complaint kit lot met release specifications. Additionally, the instrumentation and algorithm used performed as intended. The initial reactive result was most likely due to sample specific issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2016-00008 |
| MDR Report Key | 5370218 |
| Date Received | 2016-01-15 |
| Date of Report | 2016-01-29 |
| Date of Event | 2015-12-03 |
| Date Mfgr Received | 2015-12-17 |
| Date Added to Maude | 2016-01-15 |
| 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 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| 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 V2.0 CE-IVD |
| Generic Name | ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA |
| Product Code | MZP |
| Date Received | 2016-01-15 |
| Model Number | NA |
| Catalog Number | 05969492190 |
| Lot Number | 185527 |
| ID Number | NA |
| Device Expiration Date | 2016-12-31 |
| 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 |
| Manufacturer Address | 1080 US HWY 202 S NA BRANCHBURG NJ 088763733 US 088763733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-15 |