MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-04-07 for COBAS TAQMAN 48 ANALYZER 03279332001 manufactured by Roche Diagnostics, Ltd..
[1862700]
A customer in (b)(4) reported that they received discrepant hbv results when using the kit c-taq hbv 48 tests expt-ivd. The sample result was target not detected (tnd). However, the customer noticed that the growth curve showed positive growth in the normalized view. Upon repeating the sample, the result was a high titer above range. The results were not reported.
Patient Sequence No: 1, Text Type: D, B5
[9109261]
(b)(4). Computer software performance tests conducted, algorithm analysis, software / firmware caused event, unusual event. The investigation determined that the discrepant target not detected (tnd) result was caused by the baseline normalization calculation of the elth algorithm. In very rare instances, the analysis curves of the affected samples are noisy in the first few cycles. The (b)(4) curves did not have enough valid baseline points for a correct calculation of the baseline. Therefore, the data points of the plateau region were incorrectly used for the calculation of the baseline, leading to an incorrect tnd result. All affected roche molecular systems assays were assessed for risks and possible impacts due to the elth baseline normalization anomaly. All potential failure modes were analyzed. The anomaly has an extremely low rate of occurrence. (b)(4). All residual risks identified were determined to be in the acceptable or alarp (as low as reasonably practical) range. The overall residual risk was determined to be acceptable with no major impact on assay or system performance expected. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9180595]
A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing. The outcome of this investigation will be communicated through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2011-00046 |
| MDR Report Key | 2044392 |
| Report Source | 01,05 |
| Date Received | 2011-04-07 |
| Date of Report | 2011-03-13 |
| Date of Event | 2011-02-28 |
| Date Mfgr Received | 2011-03-13 |
| Date Added to Maude | 2011-06-03 |
| 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 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 TAQMAN 48 ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE, PRODUCT CODE: JJF |
| Product Code | JJF |
| Date Received | 2011-04-07 |
| Catalog Number | 03279332001 |
| Device Availability | N |
| 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-6343 SZ CH-6343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-07 |