MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-10-17 for COBAS AMPLIPREP/COBAS TAQMAN HIV-1 TEST 03542998190 manufactured by Roche Molecular Systems.
[943017]
The customer is performing a correlation between the amplicor monitor hiv-1 test, v1. 5 and the cobas ampliprep/cobas taqman hiv-1 test in order to convert their test method to the newer platform. One out of the roughly 100 samples that have been compared generated discrepant results of greater tha 0. 5 log10 hiv titer. This sample generated results of 27,252 cp/ml and 47,000 cp/ml when tested with the amplicor moniotr hiv-1 test, v1. 5. Both the original and repeat tests with the cobas ampliprep/cobas taqman hiv-1 test generated results of < 48 cp/ml. The last viral titer for this patient was determined in 2005 to be 22,517 cp/ml. The amplicor result of 27,252 cp/ml was the titer reported to the physician. There was no change to patient treatment due to the discrepant results.
Patient Sequence No: 1, Text Type: D, B5
[8159322]
The complaint cobas ampliprep/cobas taqman hiv-1 test kit batch was not tested functionally during the investigation. However, review of qc release testing results, components testing results and bulk manufacturing trendlines indicate that the kit functioned appropriately during release. Sequencing results performed on a collection from the suspect patient sample indicate the hiv-1 viral subtype is 15_01b/01_ae. The sequence contains three mismatches in the downstream (rt) primer binding region for the cobas ampliprep/cobas taqman hiv-1 test. One of the mismatches to the downstream primer is located at the third position from the 3' end of the primer. Mismatches near the 3' end of a primer may affect amplification efficiency. Among the over 9,000 sequences available in public databases that cover the downstream primer binding region for the test, 10 sequences contain the same mismatch in the third nucleotide position from the 3' end of the downstream primer binding regions as this sample. An additional fourteen in-house sequences from twelve patients contain the same n-3 mismatch from the 3' end and are associated with under-quantitation of the cobas ampliprep/cobas taqman hiv-1 test as compared to the cobas amplicor hiv-1 monitor test. Review of the cobas ampliprep/cobas taqman hiv-1 test us-ivd package insert showed:-"the test is intended to be used in conjunction with other clincial presentation and other laboratory markers of disease progress for the clinical management of hiv-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline hiv-1 rna level or to monitor the effects of anitretroviral therapy by measuring changes in edta plasma hiv-1 rna levels during the course of antiretroviral treatment". In this context, changes in therapy would not be implemented if the titer was aberrant from previous titers, the overall clinical condition and other clinical parameters. The cd4 cell count serves as the major clinical indicator of immunocompetence in patients with hiv infection and therefore is usually the most important consideration in decisions to initiate antiretroviral therapy. -"though rare, mutations within the highly conserved region of the viral genome covered by the cobas ampliprep/cobas taqman hiv-1 test primers and/or probe may result in the under-quantitation of or failure to detect the virus". -"due to inherent differences between technologies, it is recommended that, prior to switching from one technology to the next, users perform correlation studies in their laboratory to quantify technology differences". By following this recommendation, the customer identified a sample that contained a mutated virus that was not compatible with the cobas ampliprep/cobas taqman hiv-1 test. The results generated with the amplicor hiv-1 monitor test were the only results reported to the physician. There was no change to patient therapy due to the discrepant result. -"note: approximately 1. 5% of all samples tested showed lower quantitation by > 0. 5 log10 titer when compared to the cobas amplicor hiv-1 monitor test, v1. 5". This is a known issue. A reivew of complaint cases where the cobas ampliprep/cobas taqman hiv-1 test (ce-ivd and us-ivd) generated under-quantitated results when compared to a different test/product was reviewed for all complaints prior to 12 nov 2008. There are approximately 26 cases that have been verified incidents of the cobas ampliprep/cobas taqman hiv-1 test under-quantitation due to sequence mismatches between the sample sequence and the sequence of the primers near the 3' end. There are approximately ten cases of underquantitation of which the cause is unknown and may be due to sequence mismatches. Either sample was unavailable for testing or sequences could not be generated.
Patient Sequence No: 1, Text Type: N, H10
[8234431]
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 ampliprep/cobas taqman hiv-1 test should be interpreted with consideration of all clinical and laboratory findings. Due to inherent differences between technologies, it is recommended that, prior to switching from one technology to the next; users perform method correlation studies in their laboratory to quantify technology differences.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2008-00011 |
| MDR Report Key | 1198163 |
| Report Source | 05 |
| Date Received | 2008-10-17 |
| Date of Report | 2008-12-16 |
| Date of Event | 2008-09-18 |
| Date Mfgr Received | 2008-10-02 |
| Date Added to Maude | 2008-12-19 |
| 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 945880900 |
| Manufacturer Country | US |
| Manufacturer Postal | 945880900 |
| 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 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLIPREP/COBAS TAQMAN HIV-1 TEST |
| Generic Name | MONITOR TEST, HIV-1 |
| Product Code | MTL |
| Date Received | 2008-10-17 |
| Catalog Number | 03542998190 |
| Lot Number | K02014 |
| Device Expiration Date | 2008-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1238977 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HWY 202 SOMERVILLE NJ 088763771 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-17 |