MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-03-26 for COBAS AMPLIPREP/ COBAS TAQMAN 48 WITH AMPLILINK SOFTWARE V 3.2.3 manufactured by Roche Molecular Systems, Inc..
[1480394]
A customer in (b)(6) obtained a failed result for a negative control with the kit cap-g ctm hiv 48 tests expt-ivd using cobas ampliprep / cobas taqman 48 analyzer with amplilink software v. 3. 2. 3. The customer removed the rack before the negative control was processed, which caused the failure. The negative control result was "failed" and flagged with disp_error. As configured, the amplilink software was expected to invalidate all patient samples in the run batch if a control had a result of either "failed" or "invalid. " the test run should have been invalidated, as the software was configured to require that all three controls (negative control, low positive control and high positive control) must all be valid for the run to be considered valid. However, the customer reported that the failed negative control did not invalidate the patient results. The customer was performing an evaluation study for the cap-ctm 48 system. No results were reported.
Patient Sequence No: 1, Text Type: D, B5
[8663086]
The issue is under evaluation. No conclusions can be drawn at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00010 |
| MDR Report Key | 1640924 |
| Report Source | * |
| Date Received | 2010-03-26 |
| Date of Report | 2010-06-16 |
| Date of Event | 2010-03-22 |
| Date Facility Aware | 2010-03-17 |
| Date Mfgr Received | 2010-03-22 |
| Date Added to Maude | 2011-10-06 |
| 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 |
| Manufacturer G1 | ROCHE DIAGNOSTICS LTD. |
| Manufacturer Street | FORRENSTRASSE |
| Manufacturer City | ROTKREUZ, ZUG 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 0 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLIPREP/ COBAS TAQMAN 48 WITH AMPLILINK SOFTWARE V 3.2.3 |
| Generic Name | ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE |
| Product Code | JJF |
| Date Received | 2010-03-26 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | 1080 US HWY 202 BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-26 |