MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-03-08 for COBAS AMPLISCREEN HBV TEST 03302555018 manufactured by Roche Molecular Systems.
[1933392]
A customer site in the us reported that they received a (b)(6) result when using the cobas ampliscreen hbv test. The customer was running a known (b)(6) sample for re-entry into the donor pool. The samples were extracted by the multiprep method, and each extract was tested in triplicate. The sample had two (b)(6) results and one (b)(6) result and re-entry was denied. The sample was then accidently retested and all three results were (b)(6). The (b)(6) results were not reported.
Patient Sequence No: 1, Text Type: D, B5
[9041118]
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
[9250335]
(b)(4): no failure detected and product performed within specification. The customer alleged a false (b)(6) cobas ampliscreen (b)(6) test result for a donor which was originally run in triplicate and generated two (b)(6) results and one (b)(6) result. At this point, the donor would be considered (b)(6) according to the package insert. However, the customer inadvertently ran the sample again in triplicate. The inadvertent testing produced three (b)(6) results and, thus, the donor would be considered (b)(6) according to the package insert. The customer confirmed that the alleged (b)(6) results associated with this donor were not released. The donor had a reactive (b)(6) result. An aliquot of the donor sample was supplied by the customer for analysis. Viral load testing of the donor sample with the cobas ampliprep / cobas taqman (cap/ctm) (b)(6) generated a result of target not detected (tnd). Despite several attempts to obtain an (b)(4) sequence from the sample, no virus sequence was obtained. The lack of (b)(6) sequence does not necessarily mean that no (b)(6) virus is present in the sample. The lack of sequence information could be due to sequence heterogeneity under the primers used for sequencing or due to low viral titers. Due to low volume of the customer-returned sample, no further testing could be performed. Although the limit of detection (lod) for the cap/ctm (b)(4) is slightly higher than that of the cobas ampliscreen (b)(4), when using the multiprep sample processing procedure ((b)(6) iu/ml), the results obtained from the cap/ctm (b)(4), coupled with the inability to obtain a virus sequence, suggests that the cause of the cobas ampliscreen (b)(4) discrepant results observed by the customer was due to a low (b)(4) titer. This conclusion is further reinforced by the fact that this donor had a (b)(6) result. The reproducibility study outlined in the cobas ampliscreen (b)(6) test package insert shows samples with (b)(4) concentration close to the lod of the assay will produce variable results. The customer's allegation was specific to a sample from one donor and not specific to a kit batch. The controls and other donor samples in the run were valid and met specification, indicating that the test is performing as expected within the customer's laboratory. No product non-conformance was identified. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2011-00010 |
| MDR Report Key | 2009571 |
| Report Source | 05 |
| Date Received | 2011-03-08 |
| Date of Report | 2011-02-09 |
| Date of Event | 2011-01-14 |
| Date Mfgr Received | 2011-02-09 |
| 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 | 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 | 2011-03-08 |
| Catalog Number | 03302555018 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-03-08 |