MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-12-01 for COBAS TAQSCREEN MPX TEST 04584252190 manufactured by Roche Molecular Systems.
[2316143]
A customer site in (b)(6) filed a complaint stating that they generated discrepant (b)(6) results during (b)(6) 2011 and (b)(6) 2011 for 9 samples when using the cobas s201 taqscreen mpx test -us-ivd (m/n 04584252190; batch p05237). When tested with cobas ampliscreen hcv v2 test (m/n 03302563018; batch n17239), cobas ampliscreen hiv-1 v1. 5 test (m/n 03322114018; batch n09377) and cobas ampliscreen hbv test (m/n 03599779190; batch p02807), all results for the 9 samples were (b)(6). The serology test results for the 9 samples are currently unknown.
Patient Sequence No: 1, Text Type: D, B5
[9498411]
The investigation into this reported issue is ongoing, and therefore, no conclusion can be drawn at this time. The conclusion of this investigation will be reported through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9675171]
Eleven donors generated taqscreen mpx (b)(6) results during individual sample testing (resolution pooling). These 11 mpx results were discrepant to serology given that all samples were found to be serology (b)(6). Due to result discrepancies between serology and mpx testing, discriminatory testing was performed on the mpx (b)(6) samples to identify the (b)(6) viral target. (b)(6) results were obtained for the eleven donors when tested with cobas ampliscreen (cas) tests for (b)(6). All samples tested by cas were processed using standard sample processing procedure. The frequencies of occurrence for this type of result discrepancy at the customer site were 0. 06% with lot p01607 ((b)(6)), 0. 04% with lot p05237 ((b)(6)) and 0. 01% with lot p05281 ((b)(6)). The affiliate confirmed that all complaint samples were discarded and not released for donations due to the mpx (b)(6) results. Although samples were requested for investigative testing, there were no samples available for further investigation. Review of the roche test package inserts, cobas taqscreen mpx (m/n 04788362001-05en, doc rev. 5. 0, 1/2010), cas hbv test (03599833001-07en doc, doc rev 7. 0, 1/2010), cas hiv-1 v1. 5 (05120705001-02en, doc rev 2. 0 10/2009) and cas hcv v2. 0 (04711815001-02, doc rev 2. 0 5/2006), indicated the following: there are significant limit of detection (lod) differences between mpx and cas that may help explain the result discrepancies obtained by the customer when testing some of the sample with both tests. Given that the mpx test has significantly lower lods for (b)(6) relative to cas discriminatory testing, it indicates that lower viral concentrations can be detected with mpx including concentrations that are below the ranges of detection for cas testing. The mpx package insert states that an approximate 0. 12% incident rate of (b)(6) may occur in samples tested with mpx relative to serology and cobas ampliscreen test results and, in rare cases, results of alternate nucleic acid tests. In this case allegation, the reported frequencies observed at the customer site for all three complaint lots are below the expected rate of 0. 12%, indicating the mpx test is performing within product claims. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2011-00100 |
| MDR Report Key | 2354010 |
| Report Source | 05 |
| Date Received | 2011-12-01 |
| Date of Report | 2012-03-12 |
| Date of Event | 2011-09-12 |
| Date Mfgr Received | 2012-03-09 |
| Date Added to Maude | 2011-12-02 |
| 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 TAQSCREEN MPX TEST |
| Generic Name | HEPATITIS VIRAL B DNA DETECTION; BLOOD SCREENING |
| Product Code | MKT |
| Date Received | 2011-12-01 |
| Catalog Number | 04584252190 |
| Lot Number | P05237 |
| 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 | 2011-12-01 |