MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-10-04 for COBAS TAQMAN ANALYZER manufactured by Roche Diagnostics Ltd..
[1660101]
A customer in (b)(6) alleged to receive discrepant results when using the cobas (b)(6)tests. In the last 3 to 4 months, 3 titers ((b)(6)) have been over quantitated out of a total of 23,544 tests.
Patient Sequence No: 1, Text Type: D, B5
[8785537]
The cobas taqman was returned and evaluated at roche. The baseline standard deviation of the available data are well below the algorithm noise parameter settings of the test definition files, indicating there is no fluorometer malfunction. All qc acceptance criteria were met when the qc tests were performed. The fluorometer and optical path checks were tested and passed the acceptance criteria. The performed investigations showed that the observed issues are not related to the analyzer. Therefore, the root cause of the incorrect results is suspected to be related to the elth algorithm and rare growth curve anomalies. The issue of elth baseline curve anomalies is still under investigation. However, curve anomalies could still occur and may rarely result in sudden titer shifts due to the software algorithm. (b)(4). Customers have the capability to review the growth curves for anomalies should they so desire. The impact to results is considered to be minor since the (b)(6) tests are intended to be used as a monitoring tests in conjunction with the clinical presentation and other laboratory markers as an aid in assessing viral response to antiviral therapy as measured by changes in plasma nucleic acid levels. 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. Additionally, any retest result would likely generate an accurate, non-discrepant result because the occurrence of low fluorescence and baseline noise growth curves is random, rare and is not specimen related. In this case, the customer recognized the inconsistency and did not report it to the ordering physician. We recognize that this medical device report is being filed beyond the 30-day reporting timeframe as outlined within 21 cfr 803. 50. During a review of our mdr process, we determined that not all events that occurred ex-us were being assessed for mdr reportability within the united states. As a result, all potentially critical complaints (us and ex-us) filed going back to 01-jan-2008 were reassessed to determine if any of those cases represented an mdr reportable event. During the retrospective review, this event was identified as being mdr reportable. We are taking appropriate internal corrective actions to prevent recurrence of late filings.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00023 |
| MDR Report Key | 1851295 |
| Report Source | * |
| Date Received | 2010-10-04 |
| Date of Report | 2008-09-19 |
| Date of Event | 2008-09-18 |
| Date Mfgr Received | 2008-09-19 |
| Date Added to Maude | 2011-05-02 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202 |
| 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 TAQMAN ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE |
| Product Code | JJF |
| Date Received | 2010-10-04 |
| ID Number | AMPLILINK SOFTWARE V. 3.2.0 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS LTD. |
| Manufacturer Address | FORRENSTRASSE ROTKREUZ, ZUG CH-5343 SZ CH-5343 S |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-04 |