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 48 ANALYZER manufactured by Roche Diagnostics Ltd..
[14889837]
A customer in (b)(6) filed a complaint case alleging a false (b)(6) result was generated using the high pure system/cobas (b)(6). The erroneous result was discovered when the customer reviewed the growth curves and realized that a target not detected (tnd) result had been generated for a sample with a (b)(6) non-normalized growth curve. The result was not reported out and therefore it had no effect on the patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[15171867]
Review of the customer data suggests that the false (b)(6) result was generated due to a rare curve anomaly that leads to an incorrect normalization of the baseline by the algorithm. However, curve anomalies could still occur and may rarely result in sudden titer shifts due to the software algorithm. Product bulletin 232/2006 indicates that dips in baselines can arise from improper mixing of sample in the working master mix. In addition, not equilibrating the master mix and magnesium reagents to room temperature before use can also have the same effect. Other samples in the same run exhibited similar baseline dips as seen with the sample result under question, however their lower titer and later cts did not conflict with the baselining algorithm. The result was not reported out to the physician and therefore it had no effect on the patient treatment. Had the erroneous result been reported, the risk to patient would be low since the (b)(6) test is intended to be used 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00025 |
| MDR Report Key | 1851297 |
| Report Source | * |
| Date Received | 2010-10-04 |
| Date of Report | 2008-11-10 |
| Date of Event | 2008-11-10 |
| Date Mfgr Received | 2008-11-10 |
| Date Added to Maude | 2011-04-08 |
| 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 48 ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE |
| Product Code | JJF |
| Date Received | 2010-10-04 |
| ID Number | AMPLILINK SOFTWARE V. 3.2.2 |
| 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 |