MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-01-07 for COBAS AMPLIPREP/COBAS TAQMAN HIV-1 TEST 03542998190 manufactured by Roche Molecular Systems.
[997622]
The client generated hiv-1 titer results with the cobas ampliprep/cobas taqman hiv-1 test that were at least 1. 5 log10 titer less than those generated with the cobas amplicor hiv-1 monitor test.
Patient Sequence No: 1, Text Type: D, B5
[1040638]
The client generated hiv-1 titer results with the cobas ampliprep/cobas taqman hiv-1 test that were at least 1. 5 log10 titer less than those generated with the cobas amplicor hiv-1 monitor test.
Patient Sequence No: 1, Text Type: D, B5
[8173602]
Method evaluation to include sequence analysis of specimen if available. Also possible investigation using the next generation test. 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 within 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 interpretted 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 differences.
Patient Sequence No: 1, Text Type: N, H10
[8200357]
Data from the qc kit release and component manufacturing process for the device was reviewed as part of the evaluation. Results were within specifications upon release and were within trend. Results provided by the customer show the negative and high positive controls were within range and valid. However, the low positive control was not included in the runs as instructed in the package insert. The actual device was not provided by the customer for evaluation. In addition, a sequence analysis of the related specimen was not performed since a sample was not provided by the customer. The root cause of the occasional under-quantitation is likely related to mismatches near the 3'-end between the sample sequence and the sequence of the upstream and downstream taqman primers, although there can be multiple affecting factors. Revisions to the procedural limitations section of the package insert have been initiated to communicate this known phenomenon. "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. "review of the current product insert indicates that the results generated could be expected and are not indicaitve of a product nonconformance. Data presented in the method correlation section indicates that although there is a high correlation between the cobas ampliprep/cobas taqman hiv-1 test and the cobas amplicor hiv-1 monitor test, v1. 5, approximately 1. 5% of all samples tested with the cobas ampliprep/cobas taqman hiv-1 test showed lower quantitation by > 0. 5 log when compared to the cobas ampliprep/cobas amplicor hiv-1 monitor test, v1. 5. Revisions to the method correlation section of the package insert have been initiated to note this occurrence. "note: approximately 1. 5% of all samples tested showed lower quantitation by > 0. 5 log when compared to the cobas ampliprep/cobas amplicor hiv-1 monitor test, v1. 5. "a second generation of the test has been developed that includes amplification and detection of a second region (the hiv-1 ltr region in addition to the hiv-1 gag gene) which will reduce incidents of underquantitation or falirue to detect the virus due to mutations in the viral genome. Submission of a supplemental pma is anticipated for mid 2009. The cobas ampliprep/cobas taqman hiv-1 test is intended to be used as a monitoring assay and as such, it is unlikely that a physician would change a patient's treatment based on a single data point. As in this case, the patient's history and clinical manifestations would be considered before changes to treatment were made. The safety board concluded there was no likely risk to the patient and would not result in serious injury or death in this case.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2009-00001 |
| MDR Report Key | 1279183 |
| Report Source | 05 |
| Date Received | 2009-01-07 |
| Date of Report | 2009-02-16 |
| Date of Event | 2008-11-26 |
| Date Mfgr Received | 2008-12-14 |
| Date Added to Maude | 2009-04-02 |
| 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 | OT |
| 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 | 2009-01-07 |
| Catalog Number | 03542998190 |
| Lot Number | K04584 |
| Device Expiration Date | 2009-03-31 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HWY 202 SOMERVILLE NJ 08876377 US 08876 3771 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-07 |