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..
[1475982]
A (b)(6) customer reported that they received discrepant results using the cobas ampliprep / cobas taqman hiv test. The target curve showed no growth but the ct value was (b)(6). The customer reviewed the prior results for the sample and detected the discrepancy. The (b)(6) result was not reported to the physician.
Patient Sequence No: 1, Text Type: D, B5
[8759118]
Review of the data provided by the customer indicated this incident was suspected to be due to the setting of the test definition files and the elth software algorithm and not an instrument hardware issue. Because of baseline noise, the algorithm could not find enough valid baseline points to calculate the baseline properly during the normalization step. 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. The impact to results was considered to be minor since the cap/ctm hiv-1 test is intended to be used as a monitoring test 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 of the results with prior results 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 a 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 | 2243471-2010-00024 |
| MDR Report Key | 1851296 |
| Report Source | * |
| Date Received | 2010-10-04 |
| Date of Report | 2008-04-15 |
| Date of Event | 2008-04-14 |
| Date Mfgr Received | 2008-04-15 |
| 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 | 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 |