MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-10-21 for COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST 03543005190 manufactured by Roche Molecular Systems.
[8837413]
Updated to indicate "no", device problem already known (see below, this is a known issue that is captured within the product labeling). Methods, results, and conclusions were updated to reflect the outcome of the complaint investigation. Method refers to sequencing analysis. The specimen that was reported as being under-quantitated was sequenced by roche molecular systems. Sequencing analysis revealed: that for the (b)(6) test there are several mismatches to the assay probe that are likely to affect assay performance based on the location and number of mismatches present. By contrast for the tests used by the customer for comparison: for the cobas amplicor him v1. 5 test, any mismatches present under the primer and probe binding regions that are not likely to affect assay performance based on the number and location of the mismatches. For the (b)(6) test, mismatches to the gag probe are likely to affect the detection of the gag amplicon. However, any mismatches present under the ltr primers and probe are unlikely to affect amplification and detection of the (b)(6). Therefore, no sequence-related performance issues are expected for the (b)(6) test. As specified within the product labeling, though rare, mutations within the highly conserved region of the viral genome covered by the test's primers and/or probe may result in the under-quantitation of or failure to detect the virus. Based on the information available, there is no indication of a product or batch non-conformance / malfunction. Furthermore, there was report of serious injury / death associated with this reported issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9094623]
This is a correction to mdr 2243471-2010-00041 follow-up #1. Within the "manufacturer narrative," there was an omission within the last sentence. As written within mdr 2243471-2010-00041 follow-up #1, the last sentence indicated, "furthermore, there was report of serious injury / death associated with this reported issue. " however, this sentence should have read, "furthermore, there was no report of serious injury / death associated with this reported issue. " there was an inadvertent omission of the word "no" from the last sentence. Below is the full manufacturer narrative with the revised text. We apologize for any inconvenience. Updated manufacturer narrative: the specimen that was reported as being under-quantitated was sequenced by roche molecular systems. Sequencing analysis revealed: that for the (b)(6) test there are several mismatches to the assay probe that are likely to affect assay performance based on the location and number of mismatches present. By contrast for the tests used by the customer for comparison: for the (b)(6) test, any mismatches present under the primer and probe binding regions that are not likely to affect assay performance based on the number and location of the mismatches. For the (b)(6) test, mismatches to the gag probe are likely to affect the detection of the gag amplicon. However, any mismatches present under the ltr primers and probe are unlikely to affect amplification and detection of the ltr region. Therefore, no sequence-related performance issues are expected for the (b)(6) test. As specified within the product labeling, though rare, mutations within the highly conserved region of the viral genome covered by the test's primers and/or probe may result in the under-quantitation of or failure to detect the virus. Based on the information available, there is no indication of a product or batch non-conformance / malfunction. Furthermore, there was no report of serious injury / death associated with this reported issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[20628262]
An under-quantitated test result for the cobas ampliprep / cobas taqman (b)(6) test , as compared to alternative analysis, was reported from (b)(6). As indicated by the customer, no treatment was administered between the various testing dates. There was no indication of patient harm.
Patient Sequence No: 1, Text Type: D, B5
[20707191]
The issue being reported occurred with the ce-ivd version of the cobas ampliprep / cobas taqman (b)(6) test for which there is a similar us-ivd version, material number (b)(4). The investigation into this issue is ongoing; therefore, no conclusion can be drawn at this time. It has been noted that patient sample will likely be available for investigative testing by roche. Final investigative conclusions will be submitted through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00041 |
| MDR Report Key | 1879047 |
| Report Source | 01,05 |
| Date Received | 2010-10-21 |
| Date of Report | 2011-02-03 |
| Date of Event | 2010-07-17 |
| Date Mfgr Received | 2010-09-23 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2012-01-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202S |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST |
| Generic Name | TEST, HIV DETECTION |
| Product Code | MTL |
| Date Received | 2010-10-21 |
| Catalog Number | 03543005190 |
| Lot Number | N01002 |
| Device Expiration Date | 2001-03-31 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 HW 202S BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-21 |