MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-11-20 for KIT CAP-G/CTM HCV 48 TESTS VERSION 1 03568547190 manufactured by Roche Molecular Systems.
[16450861]
A customer site in (b)(6) filed a complaint alleging that discrepant results for two patient samples were generated while evaluating a correlation between (b)(6) v1. 0 and v2. 0 tests. The results of version 1. 0 were reported to the physician. It was stated that no adverse event was reported and no patient information or treatment information is available. This report will address specimen 2 with (b)(6) v1. 0. Mdr 2243471-2013-00033 will address specimen 2 with (b)(6). Mdr 2243471-2013-00030 and 31 will address specimen 1 results.
Patient Sequence No: 1, Text Type: D, B5
[16770084]
A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing. The outcome of this investigation will be communicated through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[34572070]
Date of report 1/9/2014. Date received by manufacturer 1/9/2014. Follow up report 1. Device evaluated by manufacturer yes. (b)(4). Specimen 2 generated results with the (b)(6) of (b)(6) vs. A result of (b)(6) with the (b)(6). Specimen 2 was determined to be (b)(6) genotype 6. The results of the sequencing analysis for specimen 2 determined that there is one mismatch in the downstream primer near the 3' end in the cap/ctm (b)(6) which could affect the test's performance and explain the lower (b)(4) titer generated. With the cap/ctm (b)(6). As stated in the procedural limitations section of the cap/ctm (b)(6) package insert, "though rare, mutations in the highly conserved regions of the viral genome covered by the cobas ampliprep / cobas taqman test primers and/or probe may result in the underquantitation of or failure to detect the presence of the virus in this circumstance. " retain kit testing met specifications. There is no indication of a product malfunction. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2013-00032 |
| MDR Report Key | 3478259 |
| Report Source | 01,05 |
| Date Received | 2013-11-20 |
| Date of Report | 2014-01-09 |
| Date Mfgr Received | 2013-12-23 |
| Date Added to Maude | 2014-02-27 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIT CAP-G/CTM HCV 48 TESTS VERSION 1 |
| Generic Name | ASSAY, HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HCV |
| Product Code | MZP |
| Date Received | 2013-11-20 |
| Catalog Number | 03568547190 |
| Lot Number | 101166 |
| Device Expiration Date | 2014-03-31 |
| 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 | 2013-11-20 |