MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-27 for KIT CAP/CTM HCV V2.0 72T US-IVD 05480442190 manufactured by Roche Molecular Systems.
[46793325]
A us customer filed a case indicating that they received (b)(6) results ((b)(6) vs. Target not detected) for a patient when using the cap/ctm hcv test, v2, us-ivd, lot w08173. No harm was indicated for the patient and the customer confirmed there were no treatment changes made as a result of the discrepancies. The kit was investigated and no issues were reported during quality control kit release and no related cases were filed against the specific cap/ctm hcv test, v2, us-ivd lot (w08173). The performance of the cobas ampliprep instrument and cobas taqman48 analyzer were reviewed and no issues were found - no optical malfunction was identified for the cobas taqman analyzer, and there was no evidence of a "leaky" air system or mixing issues for the cobas ampliprep instrument. When reviewing the growth curves for the sample that generated (b)(6) result, it was indicated that the affected curve showed a small dip in fluorescence in the first 5 pcr cycles. This dip made the curve shape look like sigmoidal rather than flat. Further, the rfi minimum for the curve was exceeded and the samples were considered positive. A possible cause for the dip seen could be the presence of bubbles in the reaction tubes during the manual transfer of the sample from the cobas ampliprep instrument to the cobas taqman 48 analyzer (i. E. , user handling issue). The udi for the cap/ctm hcv test, v2 us-ivd is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[46793326]
A us customer reported they generated (b)(6) test results for a patient (sample id (b)(6)) when using the cap/ctm hcv test, v2, us ivd, lot w08173. The patient sample was tested on (b)(6) 2016 and generated a result of (b)(6). The same sample was retested on (b)(6) 2016 and the result was target not detected. Another sample included in the same run on (b)(6) 2016 generated a result of(b)(6) and then repeated as target not detected. A separate mdr report (mdr 2243471-2016-00010) will address this other sample.
Patient Sequence No: 1, Text Type: D, B5
[58638098]
A us customer filed a case indicating that they received discrepant results (> 100,000,000 iu/ml vs. Target not detected) for a patient when using the cap/ctm (b)(6) test, v2, us-ivd, lot w08173. No harm was indicated for the patient and the customer confirmed there were no treatment changes made as a result of the discrepancies. A (b)(6) rna result when the cobas ampliprep/cobas taqman (b)(6) test, v2. 0 is used for diagnosis or monitoring may result in psychological distress. However, patients treated for (b)(6) are followed in specialized clinics where (b)(6) results would be identified as such after additional laboratory tests. (b)(6) guidelines recommend (b)(6) genotyping for patients with (b)(6) results and recommend resistance associated variant testing in certain circumstances. This additional testing would yield negative results; thereby, pointing towards a (b)(6) test result. A mis-diagnosis of (b)(6) in a patient with non-(b)(6) liver disease is unlikely to cause adverse health consequences since evaluation of patients with liver disease is based on clinical presentation and multiple test results but not exclusively on the (b)(6) test result. While health hazards of (b)(6) results may range from psychological distress to erroneous initiation of (b)(6) treatment with potential adverse events it is unlikely that these occur. Adverse events of new (b)(6) regimens are less common and most importantly the initiation of treatment is not based exclusively on the result of a (b)(6) test. Through the course of the investigation, no clear root cause has been identified, and corrective and preventive actions will be implemented, as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2016-00011 |
| MDR Report Key | 5685371 |
| Date Received | 2016-05-27 |
| Date of Report | 2016-10-18 |
| Date of Event | 2016-04-19 |
| Date Mfgr Received | 2016-04-27 |
| Date Added to Maude | 2016-05-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer G1 | NA |
| Manufacturer Street | NA NA |
| Manufacturer City | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIT CAP/CTM HCV V2.0 72T US-IVD |
| Generic Name | ASSAY, HYBRIDIZATION, NUCLEIC ACID AMPLIFICATION, DETECTION OF HCV RNA |
| Product Code | MZP |
| Date Received | 2016-05-27 |
| Model Number | NA |
| Catalog Number | 05480442190 |
| Lot Number | W08173 |
| ID Number | NA |
| Device Expiration Date | 2017-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-27 |