MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2008-10-16 for COBAS AMPLICOR HIV-1 MONITOR TEST, V1.5 03155935018 manufactured by Roche Molecular Systems.
[927018]
A customer reported a discrepant result obtained with the cobas amplicor hiv-1 monitor test, after reading about it in the cap today 2008. In the article, dr. Hector bolivar, m. D. At the aids clinical research unit, university of miami, fl reported a case where hiv-1 subtype diversity was observed in the us. The case involved a woman who was a recent immigrant from central america. She was treatment naive. She suffered from wasting syndrome and respiratory tract infections. The cd4 count was less than 100 cells/ulwhich was consistent with her condition. Viral load determined prior to her visit to dr's clinic was undetectable with the cobas amplicor monitor test, v1. 5. Because the viral load information did not fit the clinical picture, additional testing was performed by drs lab. Branched dna assay (siemens) generated a titer of 90,840 cp/ml and the rt pcr assay (abbott) yielded a result of 251,189 cp/ml. Sequence analysis determined the virus to be subtype f1.
Patient Sequence No: 1, Text Type: D, B5
[8099572]
Method evaluation to include sequence analysis of specimen if available. There is no evidence of product malfunction at this time. Reliable results are dependent on adequate specimen collection, transport, storage, and processing procedures. It is also possible that rare mutations with the highly conserved region of the viral genome covered by the test's primers and/or probe may result in the underquantitation of or failure to detect the virus. Results from the cobas amplicor test, v1. 5 should be interpreted with consideration of all clinical and laboratory findings.
Patient Sequence No: 1, Text Type: N, H10
[8133648]
The device was not evaluated because the batch number of the cobas amplicor hiv-1 monitor v1. 5 kit was never provided. The problematic specimen was not available for investigative testing, nor was the sequence provided. A possible explanation for why the problematic patient sample generated under-quantitated results with the cobas amplicor hiv-1 monitor test, v1. 5 at the facility is the presence of mutations within the highly conserved region of the test's primers/probes, which could lead to the under-quantitation of samples or the failure of the test to detect the presence of the virus in a patient sample as documented in the cobas amplicor hiv-1 monitor test, v1. 5 package insert. As the sample was not returned for further evaluation, it is unknown whether mismatches were present and responsible for the under-quantitated cobas amplicor hiv-1 monitor test. V1. 5 result. Review of the cobas amplicor hiv-1 monitor test, v1. 5 us-ivd package insert showed: the test is capable of detecting hiv-1 group m, subtypes a - h which is illustrated in figure 5 of the insert. These results show that the cobas amplicor hiv-1 monitor test, v1. 5 provides comparable or enhanced performance in amplification of specimens containing hiv-1 group m, subtype a - h when compared with verison 1. 0 of the same assay. The test is intended to be used in conjunction with other clinical markers/manifestations, and for monitoring the effects of antiretroviral treatments. Although the customer that made the complaint did not test the problematic patient sample cited in the journal article, the site that performed the testing performed the test as intended as they utilize the patient's clinical manifestations in conjunction with the result generated with the test to determine that additional testing was needed in order to determine the appropriate titer and sequence. Though rare, mutations in the highly conserved region of the viral genome covered by the test's primers/probes may result in under-quantiation or non-detection of viral rna. The inclusivity data generated during the development of the cobas amplicor hiv-1 monitor test, v1. 5 was reviewed and showed: hiv-1 subtype f was evaluated and detected with the test. Some of the isolates utilized during the inclusivity testing were classified as subtype f1. A complaint history search was performed on the issue of under-quantitation with the cobas amplicor hiv-1 monitor test v1. 5 and amplicor hiv-1 monitor test, v1. 5 (us-ivd and ce-ivd) since both platforms contain the same reagents and master mix with primers. Two cases were filed against the same issue of under-quantitated/discrepant results when compared to clinical markers or competitor's assay. Because thd problematic patient sample from this case was not returned for further evaluation, it cannot be specifically determined if these two cases are related to this case.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2008-00010 |
| MDR Report Key | 1197003 |
| Report Source | 03,05 |
| Date Received | 2008-10-16 |
| Date of Report | 2008-12-12 |
| Date Mfgr Received | 2008-10-01 |
| Date Added to Maude | 2008-12-12 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ROBERT PIGOZZI |
| Manufacturer Street | 4300 HACIENDA DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9257308272 |
| Manufacturer G1 | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Street | 1080 US HWY 202 |
| Manufacturer City | SOMERVILLE NJ 08876377 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08876 3771 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLICOR HIV-1 MONITOR TEST, V1.5 |
| Generic Name | MONITOR TEST, HIV-1 |
| Product Code | MTL |
| Date Received | 2008-10-16 |
| Catalog Number | 03155935018 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1236738 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HWY 202 SOMERVILLE NJ 088763771 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-16 |