MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-03-20 for CAP-CTM HCV QUANT TEST, V2.0 CE-IVD 05532264190 manufactured by Roche Molecular Systems.
[16594473]
A customer in (b)(6) filed a complaint alleging that discrepant inter and intra assay hcv results were generated for one patient when using the cobas ampliprep / cobas taqman (cap/ctm) hcv quantitative test, v2. 0 when compared to results generated with the cobas ampliprep / cobas taqman (cap/ctm) hcv qualitative test, v2. 0 and serology. The patient was reported to be hcv serology positive. The results are as follows:date sample # test result (b)(6) 2014 hcl-257 cap/ctm hcv quant target not detected (tnd) (b)(6) 2014 rhcv-129 cap/ctm hcv qual positive (b)(6) 2014 hcl-257rr cap/ctm hcv qual positive (b)(6) 2014 hcv-129 cap/ctm hcv quant 550 iu/ml (1. 74 log)
Patient Sequence No: 1, Text Type: D, B5
[16690668]
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. The associated us product code is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[34891351]
Date additional information was received by manufacturer (b)(6) 2014 device evaluated by manufacturer: yes. (b)(4). The case was filed by an australian customer for the generation of discrepant results for samples from the same patient; the cobas ampliprep/cobas taqman hcv qualitative test, v2. 0 generated positive results while the cobas ampliprep/cobas taqman hcv quantitative test, v2. 0 generated a target not detected result and a detectable titer. In the initial report 2243471-2014-00005, it was originally indicated that the cobas ampliprep/cobas taqman hcv quantitative test, v2. 0 generated a target not detected and a titer of 550 iu/ml; during the course of the investigation, it was determined that the results generated were target not detected and 55 iu/ml (550 iu/ml was erroneously provided and included in the initial report submitted). Based on all of the data provided through the global case for this patient, the target not detected result is not unexpected since the 55 iu/ml result, generated with the same test, demonstrates that the patient contains a low level hcv infection near the lower limit of quantitation of the test (15 iu/ml). A titer near the test's lower limit of quantitation is subject to the greatest variability within the test's linear range, resulting in the test not being able to consistently generated a quantifiable titer. The cobas ampliprep/cobas taqman hcv quantitative test, v2. 0 test is intended for use to monitor the infection of known-positive hcv patients. The retain kits were tested and met specifications; no issues were observed during the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2014-00005 |
| MDR Report Key | 3690201 |
| Report Source | 01,05 |
| Date Received | 2014-03-20 |
| Date of Report | 2014-03-27 |
| Date of Event | 2014-02-03 |
| Date Mfgr Received | 2014-03-27 |
| Date Added to Maude | 2014-05-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 | CAP-CTM HCV QUANT TEST, V2.0 CE-IVD |
| Generic Name | ASSAY, HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HCV |
| Product Code | MZP |
| Date Received | 2014-03-20 |
| Catalog Number | 05532264190 |
| Lot Number | 131002 |
| Device Expiration Date | 2014-11-30 |
| 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 | 2014-03-20 |