MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for COBAS MPX TEST, CE-IVD 06997708190 manufactured by Roche Molecular Systems, Inc..
[145915319]
An investigation was performed and no kit issues were identified relating to (b)(6) results. Based on the results generated for this donor, it is suspected that the donor was infected between (b)(6) 2018 and (b)(6) 2019, with a low level (b)(6) infection, which may not consistently be detected by the cobas mpx test, where serology was (b)(6) due to the lack of seroconversion (window period). The cobas mpx test, ce ivd instructions for use indicates "detection of hiv-1 group m rna, hiv-1 group o rna, hiv-2 rna, hcv rna, and hbv dna is dependent on the number of virus particles present in the sample and may be affected by sample collection, storage and handling, patient factors (i. E. , age, presence of symptoms), and/or stage of infection and pool size. " the material number for the cobas mpx test, 96t, us-ivd is 06998909190. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145915320]
A (b)(6) customer alleged the generation of a (b)(6) sample tested with the cobas mpx test for use on the cobas 6800/8800 system ((b)(6) 2019) in pool of 8. As the result in (b)(6) 2019 matched (b)(6) serology results, the donation was released and there are two recipients of this donation. It is confirmed that one patient received the thrombocyte concentrate and is being monitored. There is no information regarding if the second patient received the erythrocyte concentrate. In (b)(6) 2019, the customer received an anonymous call requesting that the donor be drawn and tested again. A new donation and previous donations from (b)(6) 2019 and (b)(6) 2018 were tested in (b)(6) 2019. The new donation and the donation from (b)(6) 2019 generated (b)(6) results and the donation from (b)(6) 2018 generated (b)(6) results. The serology for this donor was (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2019-00021 |
| MDR Report Key | 8634629 |
| Date Received | 2019-05-22 |
| Date of Report | 2019-08-20 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-05-02 |
| Date Added to Maude | 2019-05-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA STACIE-ANN CREIGHTON |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537112 |
| Manufacturer G1 | NA |
| Manufacturer Street | NA NA |
| Manufacturer City | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COBAS MPX TEST, CE-IVD |
| Generic Name | ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA |
| Product Code | MZP |
| Date Received | 2019-05-22 |
| Model Number | NA |
| Catalog Number | 06997708190 |
| Lot Number | E10866 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-22 |