MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-05-13 for CAP-CTM HCV QUANT TEST, V2.0 CE-IVD 05532264190 manufactured by Roche Molecular Systems.
[4385264]
A customer in poland filed a complaint alleging discrepant results for a patient between the cobas ampliprep/cobas taqman (cap/ctm) (b)(4) qualitative test, v2. 0 and the cobas ampliprep/cobas taqman (b)(4) quantitative test, v2. 0. The results are as follows: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[11904941]
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
[34966517]
Date additional information was received by the manufacturer (26-jun-2014). Follow up report 1. Additional information/ device evaluation. Device evaluation by the manufacturer - yes. (b)(4). A customer from poland alleged discrepant results for a patient when samples were tested with the cobas ampliprep/cobas taqman (cap/ctm) (b)(6) quantitative test, v2. 0 (result: target not detected) and the cap/ctm (b)(6) qualitative test, v2. 0 (results: (b)(6)). Roche medical and scientific affairs assessed the provided data and suggested that the series of results for the patient could be due to the patient having a low titer during the early stages of infection; as the patient sample was not returned for further evaluation, no additional testing would be performed to identify the cause. Testing of the retain kit met specifications and no issues were identified during manufacturing of the kit; as such, no malfunction was identified. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2014-00014 |
| MDR Report Key | 3807165 |
| Report Source | 01,05 |
| Date Received | 2014-05-13 |
| Date of Report | 2014-06-26 |
| Date of Event | 2014-04-11 |
| Date Mfgr Received | 2014-06-26 |
| Date Added to Maude | 2014-06-25 |
| 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 QUANT TEST, V2.0 CE-IVD |
| Generic Name | ASSAY, HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HCV |
| Product Code | MZP |
| Date Received | 2014-05-13 |
| 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 | 2014-05-13 |