MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-08 for CAP/CTM HCV TEST, V2.0 05480442190 manufactured by Roche Molecular Systems.
[52769849]
The investigation into the case issue is currently on-going. A supplemental report will be provided at the end of the investigation. The common device name in the mdr form was truncated due to character limitations. The common device name for this device is "assay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus". (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[52769850]
A customer from the united states reported the generation of over-quantitated (b)(6) results for 1 patient (id: (b)(6)) when tested with the cobas ampliprep/cobas taqman hcv test, v2. 0 quant (lot w16347). The over-quantitated results were > 100,000,000 iu/ml. It was indicated that the amplification curves generated for the > 100,000,000 iu/ml result did not present what would appear to be a high titer sample. Upon repeat testing, a target not detected (tnd) result was generated. No other samples were affected in the run and all samples/controls were valid. No harm was indicated through the case.
Patient Sequence No: 1, Text Type: D, B5
[58748455]
A customer from the united states reported the generation of over-quantitated hcv results for 1 patient (id:(b)(6) ) when tested with the cobas ampliprep/cobas taqman hcv test, v2. 0 quant (lot w16347). The over-quantitated result was > 100,000,000 iu/ml and the customer questioned the growth curve and ct value generated. As such, repeat testing was ordered. Upon repeat testing, a target not detected (tnd) result was generated. No harm was indicated through the case. A false positive (b)(6) rna result when the cobas ampliprep/cobas taqman hcv 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 (b)(6) results; thereby, pointing towards a (b)(6) test result. A mis-diagnosis of (b)(6) in a patient with (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 hcv 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 | 2243471-2016-00015 |
| MDR Report Key | 5853780 |
| Date Received | 2016-08-08 |
| Date of Report | 2016-10-18 |
| Date of Event | 2016-07-18 |
| Date Mfgr Received | 2016-07-18 |
| Date Added to Maude | 2016-08-08 |
| 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 Phone | 9082537569 |
| 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 | CAP/CTM HCV TEST, V2.0 |
| Generic Name | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR HCV |
| Product Code | MZP |
| Date Received | 2016-08-08 |
| Model Number | NA |
| Catalog Number | 05480442190 |
| Lot Number | W16347 |
| ID Number | NA |
| Device Expiration Date | 2017-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-08-08 |