MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-05-20 for COBAS TAQMAN HBV TEST FOR USE WITH HIGH PURE SYSTEM 03577163190 manufactured by Roche Molecular Systems.
[20392004]
No investigation is warranted at this time. The customer released results on an invalid run, which is an off label practice that is not supported by the product labeling. This case does not warrant the filing of an mdr as no device-related deaths, serious injuries, or reportable malfunctions were identified. However, as per previous discussion with the fda, cdrh, a mdr will be filed to alert fda of occurrences where a customer site has reported invalid test results. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[20412032]
A customer site in the united states using the cobas taqman hbv test for use with the high pure system performed a run with two sets of roche controls. One of the high positive controls was qs_invalid, resulting in an invalid run. However, the customer released the results, which is an off label practice that is not supported by the product labeling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2011-00058 |
| MDR Report Key | 2097758 |
| Report Source | 05 |
| Date Received | 2011-05-20 |
| Date of Event | 2011-04-09 |
| Device Manufacturer Date | 2010-10-07 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS TAQMAN HBV TEST FOR USE WITH HIGH PURE SYSTEM |
| Generic Name | HEPATITIS VIRAL B DNA DETECTION |
| Product Code | MKT |
| Date Received | 2011-05-20 |
| Catalog Number | 03577163190 |
| Lot Number | N11848 |
| Device Expiration Date | 2012-05-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HW 202S BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-20 |