MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-12-19 for CAP CTM HCV TEST 03568547190 manufactured by Roche Molecular Systems.
[3973608]
A customer site in (b)(6) filed a complaint case for a patient who generated discrepant results between the cobas ampliprep/cobas taqman hcv qualitative test, v2. 0 ce-ivd and the cobas ampliprep/cobas taqman hcv test, ce-ivd. The patient had generated (b)(6) results for (b)(6) with the cobas ampliprep/cobas taqman (cap/ctm) hcv qualitative test, v2. 0 ce-ivd. After the initial (b)(6) cap/ctm hcv qualitative test, v2. 0 result was obtained, the patient was tested with the cap/ctm hcv test, ce-ivd (quantitative) a few days later and a target not detected (tnd) result was obtained. It is unknown if the same sample was used for the testing performed. No further information relating to the patient was provided. Since the (b)(6) results agree with the (b)(6) results obtained with the cap/ctm hcv qualitative test, v2. 0, the issue is being investigated as a potential under-quantitation with the cap/ctm hcv test, which generated a tnd result.
Patient Sequence No: 1, Text Type: D, B5
[11457518]
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. An equivalent product exists in the us: cap/ctm hcv test us-ivd. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2013-00039 |
| MDR Report Key | 3528641 |
| Report Source | 01,05 |
| Date Received | 2013-12-19 |
| Date of Report | 2013-11-22 |
| Date of Event | 2013-11-19 |
| Date Mfgr Received | 2013-11-22 |
| Date Added to Maude | 2014-03-31 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 TEST |
| Generic Name | ASSAY, HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HCV |
| Product Code | MZP |
| Date Received | 2013-12-19 |
| Catalog Number | 03568547190 |
| Lot Number | 110888 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2013-12-19 |