MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-03-19 for COBAS AMPLIPREP / COBAS AMPLICOR HCV TEST, V2.0 CE-IVD 03576698190 manufactured by Roche Molecular Systems.
[4289552]
A customer site in (b)(6) filed a complaint alleging that discrepant hcv results were generated for one patient sample when tested with the cobas ampliprep / cobas amplicor (cap/ca) hcv test, v2. 0. On (b)(6)-2014, the test generated a (b)(6) hcv result. When repeated on (b)(6)-2014, the result was hcv (b)(6). The customer stated that the patient previously tested (b)(6) with the cap/ca hcv test, v2. 0 on (b)(6)-2013, although no data was provided for that sample. The patient's hcv titer is unknown and it is unknown if they are on treatment.
Patient Sequence No: 1, Text Type: D, B5
[11668848]
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
[34902925]
Date of report 4/8/2014. Date received by manufacturer 4/8/2014. Device evaluated by manufacturer: yes. Result: device performed according to specifications. Conclusion: no failure detected and product within specification. The patient tested (b)(6) on (b)(6) 2013. A new sample from the same patient was collected on (b)(6) 2014 and generated a (b)(6) result. The same sample was tested on (b)(6) 2014, along with the first sample and both generated (b)(6) results. Additional information was received that genotyping was also performed on the patient sample collected (b)(6) 2014 with the siemen's lipa test on (b)(6) 2014 , but the result was very weak and was determined by the physician to be (b)(6). Subsequent testing of the older sample from (b)(6) 2013 generated a result of (b)(6). Analysis of raw data submitted by the customer indicated that the (b)(6) result generated on (b)(6) 2014 did not show any signs of pcr inhibition that could have led to the (b)(6) result. The (b)(6) target signal of the (b)(6) 2014 (b)(6) result was robust. , eliminating the possibility of the (b)(6) result having been due to a low amount of (b)(4) target material in the sample. It is possible that a sample mix-up could have occurred but that cannot be confirmed. Although requested, the complaint sample was not available for investigative testing. Testing of the complaint kit lot met specifications. Based on the information available, there is no indication of a product non-conformance. The cause of the (b)(6) result generated with the cap/ca (b)(4) test cannot be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2014-00004 |
| MDR Report Key | 3689192 |
| Report Source | 01,05 |
| Date Received | 2014-03-19 |
| Date of Report | 2014-04-08 |
| Date of Event | 2014-01-24 |
| Date Mfgr Received | 2014-04-08 |
| 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 202 S |
| 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 | COBAS AMPLIPREP / COBAS AMPLICOR HCV TEST, V2.0 CE-IVD |
| Generic Name | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HCV |
| Product Code | MZP |
| Date Received | 2014-03-19 |
| Catalog Number | 03576698190 |
| Lot Number | S06949 |
| Device Expiration Date | 2014-05-31 |
| 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 | 2014-03-19 |