MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,04 report with the FDA on 2009-04-07 for COBAS AMPLIPREP/COBAS TAQMAN HIV-1 TEST 03542998190 manufactured by Roche Molecular Systems.
[1064792]
During the course of validation of the cobas ampliprep/cobas taqman (b)(4) test, results compared to those previously generated using the cobas ampliprep/cobas amplicor (b)(4) test were discrepant.
Patient Sequence No: 1, Text Type: D, B5
[8184456]
Sequence analysis may not be performed as specimen volumes are limited. The customer is in the process of determining availability of specimens. The dilution of samples in water is an off-label use of the product and may cause inaccurate results. The package insert instructs to use with only human plasma collected in edta anticoagulant and dilute the original specimen with (b)(4) negative human edta-plasma if the result it greater than 10,000,000 cp/ml. Reliable results are dependent on adequate specimen collection, transport, storage and processing procedures. Although the customer reported storing the specimens at - 20 degrees c between tests, it is possible that the number of freeze thaw cycles or other factors may have changed the specimen since the initial testing with the cobas ampliprep/cobas amplicor (b)(4) test. Though rare, mutations within the viral genome covered by the nucleic acid test's primers or probes 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. The cobas ampliprep/cobas taqman (b)(4) 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 singe data point. The patient's history and clinical manifestations would be considered before changes to treatment were made. In this case, the results from the validation study were not reported out and therefore did not affect treatment. The safety board concluded there was no likely risk to the patient and would not result in serious injury or death in this case. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2009-00008 |
| MDR Report Key | 1355757 |
| Report Source | 02,04 |
| Date Received | 2009-04-07 |
| Date of Report | 2009-04-07 |
| Date of Event | 2009-03-01 |
| Date Mfgr Received | 2009-03-16 |
| Date Added to Maude | 2010-02-22 |
| 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 | 3 |
| 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 |
| 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 | 2009-04-07 |
| Catalog Number | 03542998190 |
| Lot Number | K15068 |
| Device Expiration Date | 2009-09-30 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Eval'ed by Mfgr | * |
| 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 | 2009-04-07 |