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.
[2515398]
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
[9593082]
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
[9836486]
Date of follow-up information was received. Follow up report 1. Device evaluated by manufacturer yes. No product or batch non-conformance was identified. Upon investigation there was no trend found in the field. Qc release data for p05203 was reviewed and the issue of discrepant results has not been observed. There have not been any manufacturing non-conformance reports for batch p05203. Retain testing of complaint batch p05203 was tested for this case and generated valid and acceptable results. No (b)(6) results were observed. The customer provided the samples for further evaluation; however, there was insufficient volume to conduct any testing with the samples while using the cobas ampliscreen hbv test. The sample was returned for further investigation and sent for sequencing analysis. The lack of (b)(6) sequence obtained from the sample does not necessarily mean that no (b)(6) virus is present in this sample. The lack of sequence information could be due to sequence heterogeneity under the primers used for sequencing and/or due to low viral titers. The discrepant results observed may be due to: the cobas taqscreen mpx test has a limit of detection (lod) for (b)(6) of (b)(6) as stated in the cobas taqscreen mpx test package insert. The lod of the cobas ampliscreen hbv test with the standard sample preparation method is 15. 99 iu/ml according to the cobas ampliscreen hbv test package insert. Thus if the samples contained a titer between 15. 99 iu/ml and 3. 8 iu/ml a (b)(6) result may have been generated during cobas ampliscreen hbv testing. Within the procedural limitations section of the cobas ampliscreen hbv test package insert, it states that "though rare, mutations within the highly conserved regions of the viral genomes covered by the cobas ampliscreen hbv test primers and/or probes may result in failure to detect a virus. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2012-00007 |
| MDR Report Key | 2434117 |
| Report Source | 05 |
| Date Received | 2012-02-01 |
| Date of Report | 2012-05-03 |
| Date of Event | 2011-12-05 |
| 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 |