MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-11-26 for COBAS TAQSCREEN MPX TEST, CE-IVD 04584244190 manufactured by Roche Molecular Systems.
[5225534]
A customer site in (b)(6) filed a complaint alleging that a (b)(6) results were generated when using the cobas taqscreen mpx test, ce-ivd. The customer generated (b)(6) results for a donor sample tested with the mpx test in pools of six and pools of one. However, upon retesting the blood bag sample, a (b)(6) mpx result was generated with pools of one. The donor serology was (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[12528196]
A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing. The outcome of the investigation will be communicated through a follow-up report. The corresponding us mpx test is m/n 4584252190 bl125255 (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[35238564]
(b)(4). The customer obtained non-reactive results for a donor sample tested during cobas taqscreen mpx primary pools of 6 and primary pools of 1 (pp6 and pp1). However the donor was found to be hbv serology positive. Due to the discrepant results obtained, the customer retested the donor's blood bag sample, and a reactive mpx pp1 result was obtained with a ct of 48. Additional testing with the cobas taqscreen mpx test was performed along with another nat test, the procleix ultrio assay. Both tests generated non-reactive results, matching the original results obtained with the cobas taqscreen mpx test. The result discrepancies in this complaint may be caused by the presence of a (b)(6) in the complaint sample. Review of qc release data for the 0. 5x lod (b)(6) panel generated a ct of approximately 35. A late ct of 48 in this case suggests the presence of a (b)(6) present in the complaint sample. Retain testing of the complaint lot was performed and testing did not reproduce the customer's allegation. There is no indication of a product non-conformance and the product is performing as intended. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2014-00019 |
| MDR Report Key | 4281108 |
| Report Source | 01,05 |
| Date Received | 2014-11-26 |
| Date of Report | 2015-01-14 |
| Date of Event | 2014-10-27 |
| Date Mfgr Received | 2015-01-14 |
| Date Added to Maude | 2014-12-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202S |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS TAQSCREEN MPX TEST, CE-IVD |
| Generic Name | HEPATITIS VIRAL B DNA DETECTION |
| Product Code | MKT |
| Date Received | 2014-11-26 |
| Catalog Number | 04584244190 |
| Lot Number | 158587 |
| Device Expiration Date | 2015-12-31 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HW 202S BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-26 |