MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-09 for COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 05480442190 manufactured by Roche Molecular Systems.
[67382118]
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
[67382119]
A customer from the united states reported the generation of an over-quantitated hcv result for 1 patient when tested with the cobas ampliprep/cobas taqman hcv test, v2. 0 (lot x03082). The over-quantitated result was > 100,000,000 iu/ml. The result was reported out but then flagged by the customer's system because it was a patient who always tested as "target not detected". The customer retested the sample and obtained an expected "target not detected" result. The customer indicated that the pcr growth curve from the first test looked like a "target not detected" result, except for a small spike in the growth curve. The customer confirmed that even though the result was reported out that there was no adverse event or change in treatment with the patient.
Patient Sequence No: 1, Text Type: D, B5
[75635512]
A customer from the united states reported the generation of an over-quantitated (b)(6) result for 1 patient when tested with the cobas ampliprep/cobas taqman hcv test, v2. 0 (lot x03082). The over-quantitated result was (b)(6). The customer indicated that the pcr growth curve from the first test looked like a "target not detected" result, except for a small spike in the growth curve. Capa was initiated for the complaint issue. Investigation has shown that the k-tips, consumables utilized for re-suspension and to transfer prepared samples into master mix for amplification/detection could have contributed to the issue. The root cause investigation is on-going via the capa case. Corrective and preventive actions will be implemented as appropriate. A (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 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2017-00002 |
| MDR Report Key | 6313967 |
| Date Received | 2017-02-09 |
| Date of Report | 2017-05-05 |
| Date of Event | 2017-01-08 |
| Date Mfgr Received | 2017-01-12 |
| Date Added to Maude | 2017-02-09 |
| 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 TIMOTHY BLAIR |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537918 |
| 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 | COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 |
| Generic Name | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR HCV |
| Product Code | MZP |
| Date Received | 2017-02-09 |
| Model Number | NA |
| Catalog Number | 05480442190 |
| Lot Number | X03082 |
| ID Number | NA |
| Device Expiration Date | 2017-09-30 |
| 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 | 2017-02-09 |