MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-11-03 for COBAS TAQSCREEN MPX TEST 04584252190 manufactured by Roche Molecular Systems.
[4968727]
Roche molecular systems was notified by a blood center in the u. S of the following issue while using the cobas taqscreen mpx test. An organ donor, whose heart was still beating at the time of the blood draw, had blood tested in primary pools of one (pp1) using the cobas taqscreen mpx test on (b)(6) 2013. The organ donor generated serology negative results for (b)(6) and non-reactive results for the mpx test. The organs were transplanted into 3 transplant recipients within 24 hours of the donor passing. The recipients tested (b)(6) in (b)(6) 2014; one recipient has passed away due to unrelated issues and the other two recipients are being closely monitored and responding well to (b)(6) treatment. The blood center noted that the donor was high risk and that the blood center did their part in informing the surgeons and surgeons did their part in receiving proper consent from the recipients.
Patient Sequence No: 1, Text Type: D, B5
[12549858]
The blood center was contacted by the organ procurement organization and requested that the donor's archive sample be send to the center for disease control (cdc) for evaluation in 2014. The cdc results showed pre-transplant serum from the high risk donor to be (b)(6) detectable at less than (b)(6). The donor splenocytes from organ procurement showed a titer of (b)(6). It is unknown which tests the cdc used to generate these two results. The results of (b)(6) obtained by the cdc indicate that the sample contains a low concentration of (b)(6) particles. According to the package insert 4788362001-10en doc rev 10, the limit of detection of the cobas taqscreen mpx test, for use with the cobas s 201 system by probit analysis is (b)(6). At or below the limit of detection, only a small number of target molecules may be delivered to each reaction tube during sample processing. As such, a sample containing a low number of target molecules is expected to generate variable results as the concentration of viral particles approaches the test's limit of detection and can result in a sample generating non-reactive results. The donor draw was obtained during the window period of infection for (b)(6) since serology and mpx results were non-reactive, yet there may have been a very low concentration of (b)(6) present in the sample that was undetected at the time of testing. No product nonconformance was identified and the cobas taqscreen mpx test performed as intended. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[23527114]
Date of report 11/14/2014. Follow up report 1. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2014-00018 |
| MDR Report Key | 4221508 |
| Report Source | * |
| Date Received | 2014-11-03 |
| Date of Report | 2014-11-14 |
| Date of Event | 2013-11-07 |
| Date Mfgr Received | 2014-10-16 |
| Date Added to Maude | 2014-11-03 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS TAQSCREEN MPX TEST |
| Generic Name | ASSAY,HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA, AND HBV DNA |
| Product Code | MZP |
| Date Received | 2014-11-03 |
| Catalog Number | 04584252190 |
| Lot Number | S00979 |
| Device Expiration Date | 2015-02-28 |
| 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 | 1. Required No Informationntervention | 2014-11-03 |