MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-04-11 for COBAS TAQSCREEN MPX TEST CE-IVD 04584244190 manufactured by Roche Molecular Systems.
[4480458]
Customer in (b)(6) alleges that 3 (b)(6) results were generated using the cobas taqscreen mpx v 1. 0 test using pools of 6. There is no indication that resolution pool of 1 has been run. Three samples were (b)(6) with (b)(6). There is no raw data available nor exact date of testing other than the info that the customer in (b)(6) run the sample in (b)(6). The 'affected' blood unit was not released for donation. This mdr will address the results of sample 1. The mdr 2243471-2014-00011 will address the results of sample #2. The mdr 2243471-2014-00012 will address the results of sample #3.
Patient Sequence No: 1, Text Type: D, B5
[11837418]
A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing. The outcome of the investigation will be communicated through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33379134]
(b)(4). The customer generated three discrepant results with the cobas taqscreen mpx test relative to serology testing. Three donor samples tested in primary pools of 6 (pp6) with the mpx test generated mpx (b)(6) results. However, the three donors were (b)(6) serology (b)(6). Further confirmatory testing for (b)(6) using a recombinant immunoblot assay (riba) confirmed the three donor samples were (b)(6). Due to the discrepant results obtained, the three donor samples were not released for donations. The datafiles containing the complaint data could not be provided for review, as the results had been purged from the customer's cobas s 201 system. This mdr addresses sample #1. There was insufficient sample volume left to perform resolution testing with the cobas taqscreen mpx test to investigate. Therefore, the customer returned sample was tested with the cobas? Taqman hcv test, v2. 0 for use with the high pure system and a 'target not detected' (tnd) result was obtained for the sample. The lod of the cobas taqman? Hcv test, v2. 0 for use with the high pure system is 20 iu/ml while the lod of the (b)(6) target used by the customer (mpx test using pp6) is 66 iu/ml. This tnd result does not necessarily mean the (b)(6) target is not present in the sample but the absence of detection could also be due to the (b)(6) titer in the sample being below the lod of the (b)(6) test used. As 'target not detected' results were obtained for the sample during testing with the cobas? Taqman? Hcv test, genetic sequencing was performed with the remaining volume to determine if there were any sequence mismatches in the sample that may explain the result discrepancies reported in this case. The following conclusions were made from the genetic sequencing results: despite several attempts to obtain (b)(6) sequences from the customer returned sample, no viral sequences were obtained. The lack of (b)(6) sequence does not necessarily mean that no (b)(6) virus was 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. Retain testing of the complaint lot 122992 generated valid results for all controls and qc standards tested with no discrepant results obtained. The retain testing results confirm appropriate test performance and functionality of the complaint kit lot. According to the mpx package insert (m/n 05888212001, doc rev. 9. 0), the discrepant results obtained in this global case may be explained by: 1)mutations present in the mpx detection target region which can result in failure to detect the hcv target and/or 2) low (b)(6) viral titers present in the sample tested. The mpx test is most sensitive during individual donor testing than during pp6 testing. This is because the limit of detection of the mpx test during individual donor testing for the (b)(6) target is 11 iu/ml and 66 iu/ml during pp6 testing. The tnd result generated with the cobas taqman? Hcv test, v2. 0 for use with the high pure system indicates that it is below the lod of the test, which is 20 iu/ml. Given that mutations within the highly conserved regions of the viral genomes covered by the cobas? Taqscreen mpx test primers and/or probes are rare, the most likely cause for the discrepant results is the presence of a low hcv titer in the sample during pp6 testing. Review of cdc interpretation of results of test for (b)(6) infection and further actions indicate that a test outcome of serology (b)(6) rna not detected is interpreted as no current (b)(6) infection as this scenario can occur in patients that have had exposure and/or treatment for (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2014-00010 |
| MDR Report Key | 3745749 |
| Report Source | 01 |
| Date Received | 2014-04-11 |
| Date of Report | 2014-06-19 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-06-19 |
| Date Added to Maude | 2014-06-05 |
| 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 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 TAQSCREEN MPX TEST CE-IVD |
| Generic Name | ASSAY,HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA, AND HBV DNA |
| Product Code | MZP |
| Date Received | 2014-04-11 |
| Catalog Number | 04584244190 |
| Lot Number | 122992 |
| Device Expiration Date | 2014-08-30 |
| 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 | 2014-04-11 |