MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-11 for COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD 05969492190 manufactured by Roche Molecular Systems.
[108613600]
The investigation into this issue is currently on-going. The outcome of this investigation will be communicated through a follow-up report. The udi for the cobas taqscreen mpx test, v2. 0, ce-ivd is (b)(4). The corresponding us kit material number is 05969484190. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[108613601]
A customer in (b)(6) reported 2 false non reactive cobas taqscreen mpx test, v2. 0 results compared to the positive serology results. Donor 1 was non reactive with the cobas taqscreen mpx test, v2. 0 but (b)(6) in serology test. Donor 2 was non reactive with the cobas taqscreen mpx test, v2. 0 but (b)(6) surface antigen (b)(6) in serology. The results were not released and the blood units were removed and placed in quarantine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2018-00007 |
| MDR Report Key | 7507743 |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-30 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-04-13 |
| Date Added to Maude | 2018-05-11 |
| 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 STACIE-ANN CREIGHTON |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537112 |
| 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 | 0 |
| 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 | 2018-05-11 |
| Model Number | NA |
| Catalog Number | 05969492190 |
| Lot Number | 268173 |
| ID Number | NA |
| Device Expiration Date | 2019-02-28 |
| 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 |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-11 |