MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-15 for COBAS MPX TEST, CE-IVD 06997708190 manufactured by Roche Molecular Systems, Inc..
[108400541]
An investigation was performed and no kit issues were identified relating to (b)(6) results. Based on the results generated for this donor, the donor was (b)(6) infected in (b)(6) with a low level (b)(6) infection, which may not consistently be detected by the cobas mpx test, where serology was negative 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. " (b)(6). The udi for the cobas mpx test, ce-ivd is (b)(4). The material number for the cobas mpx test, 96t, us-ivd is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[108400542]
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) 2018). Blood was released after (b)(6) 2018 testing results as the resolved cobas mpx test and serology results were (b)(6). Subsequent testing ((b)(6) 2018) for the same donor (new donation) generated (b)(6) results with the cobas mpx test and serology. There is no indication of harm or injury to any of the recipients who may have received the blood donations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2018-00008 |
| MDR Report Key | 7516448 |
| Date Received | 2018-05-15 |
| Date of Report | 2018-05-15 |
| Date of Event | 2018-01-23 |
| Date Mfgr Received | 2018-04-19 |
| Date Added to Maude | 2018-05-15 |
| 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 | 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 | MTL |
| Date Received | 2018-05-15 |
| Model Number | NA |
| Catalog Number | 06997708190 |
| Lot Number | 242567 |
| ID Number | NA |
| Device Expiration Date | 2019-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-05-15 |