MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-11 for COBAS TAQSCREEN MPX TEST V2.0 CE-IVD 05969492190 manufactured by Roche Molecular Systems.
[72784508]
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
[72784509]
A customer from (b)(6) reported a discrepancy between the cobas taqscreen mpx test, v2. 0, chemiluminescence testing, abbott testing and the cobas ampliprep/cobas taqman (cap/ctm) hiv-1 test, version 2. 0. The sample was (b)(6) for (b)(6) on all tests other than cobas taqscreen mpx test, v2. 0. The abbott test generated a (b)(6) result value of (b)(6) and the cap/ctm test generated a titer of (b)(6). The customer tested, with cobas taqscreen mpx test v2. 0, a total of three samples from the donor a total of four times (the first sample was tested twice) in primary pools of 1 (pp1) and each time it generated non-reactive results. The result was delivered to the donor and the blood bag was discarded. According to the anonymous questionnaire filled out by the donor prior to donation there is no medical history of hiv infection or treatment provided. This mdr is specific to the non-reactive results generated with the cobas taqscreen mpx test, v2. 0.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2017-00011 |
| MDR Report Key | 6482992 |
| Date Received | 2017-04-11 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-03-13 |
| Date Mfgr Received | 2017-03-15 |
| Date Added to Maude | 2017-04-11 |
| 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 |
| 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 | 2017-04-11 |
| Model Number | NA |
| Catalog Number | 05969492190 |
| Lot Number | 219650 |
| ID Number | NA |
| Device Expiration Date | 2017-11-30 |
| 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 | 2017-04-11 |