MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-02-01 for COBAS AMPLISCREEN HBV TEST 03599779190 manufactured by Roche Molecular Systems.
[2514910]
A customer site in the united states alleged discrepant results were generated with the cobas ampliscreen hbv test. Specifically, the customer stated that four samples generated (b)(6) test results, for (b)(6), when tested with the cobas ampliscreen hbv test. The four samples tested (b)(6) with the cobas taqscreen mpx test as well as an unknown serology test. The (b)(6) results were released to the physician one medical device report per donation is being filed (mdr numbers 2243471-2012-00004 though -00007).
Patient Sequence No: 1, Text Type: D, B5
[9592577]
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
[9836121]
(b)(4): no failure detected and product performed within specification. The sample was sent for sequencing and it was determined that the sequences that cover the (b)(6) target region were obtained and determined to be (b)(6). Any mismatches to the cobas ampliscreen (b)(4) primer and probe binding regions are unlikely to affect assay performance based on the location and number of mismatches present. The lack of detection of (b)(6) with the cobas ampliscreen (b)(6) test for this sample may be due to low viral titers. Note: initially the customer had indicated that sample (b)(4) displayed discrepant results between testing with cobas ampliscreen (b)(6) test and cobas taqscreen mpx test and serology; however, review of the cobas ampliscreen (b)(6) data displayed valid (b)(6) results for the sample, which correlated with the cobas taqscreen mpx test and serology result. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2012-00004 |
| MDR Report Key | 2434133 |
| Report Source | 05 |
| Date Received | 2012-02-01 |
| Date of Report | 2012-05-03 |
| Date of Event | 2011-11-14 |
| Date Mfgr Received | 2012-05-03 |
| Date Added to Maude | 2012-08-10 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLISCREEN HBV TEST |
| Generic Name | HEPATITIS VIRAL B DNA DETECTION |
| Product Code | MKT |
| Date Received | 2012-02-01 |
| Catalog Number | 03599779190 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-02-01 |