MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for COBAS TAQSCREEN MPX TEST, V2.0 5969492190 manufactured by Roche Molecular Systems, Inc..
[139417362]
An investigation was performed on kit lots 225191 and 303115, and no issues were identified relating to (b)(6) results. Based on the ct values generated for this donor, the donor may have been (b)(6) infected in (b)(6) 2018 with a low level infection, which may not consistently be detected by the cobas taqscreen mpx test, v2. 0. As serology ((b)(6)) was consistently (b)(6) and the cobas taqscreen mpx test, v2. 0 generated a mixture of (b)(6) results for this donor in pp1 at later time points ((b)(6) 2018 and (b)(6) 2019) with lot 303115, it may be an indication that the donor has a low level chronic (b)(6) infection. The cobas taqscreen mpx test, v2. 0 ce ivd instructions for use indicates "detection of hiv-1 group m rna, hiv-1 group o rna, hiv-2 rna, hcv rna and hbv dna is dependent on the number of virus particles present in the specimen and may be affected by specimen collection methods, patient factors (i. E. Age, presence of symptoms), and/or stage of infection and pool size. " the material number for the cobas taqscreen mpx test, v2. 0 us-ivd: 05969484190. The udi for the cobas taqscreen mpx test, v2. 0 us-ivd: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139417363]
A customer in russia alleged the generation of discrepant (b)(6) results for a donor when tested with the cobas taqscreen mpx test, v2. 0. During the original donation ((b)(6) 2018), the donor generated (b)(6) results with the cobas taqscreen mpx test, v2. 0 (lot 225191) in pp1, which matched (b)(6); as such, the donation was released. During two, subsequent donations ((b)(6) 2018 and (b)(6) 2019), the donor generated a mixture of (b)(6) results with the cobas taqscreen mpx test, v2. 0 (lot 303115) in pp1. Serology ((b)(6)) for these donations was still (b)(6), and the donations were not released. No information on the status of the recipient(s) has been provided to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2019-00012 |
| MDR Report Key | 8438106 |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-02-21 |
| Date Mfgr Received | 2019-02-26 |
| Date Added to Maude | 2019-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Generic Name | ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA |
| Product Code | MZP |
| Date Received | 2019-03-20 |
| Model Number | NA |
| Catalog Number | 5969492190 |
| Lot Number | 225191 |
| Device Expiration Date | 2018-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 2019-03-20 |