MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-23 for COBAS MPX TEST, CE-IVD 06997716190 manufactured by Roche Molecular Systems, Inc..
[124796225]
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 likely (b)(6) 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. " the material number for the cobas mpx test, 480t, us-ivd is 06998917190. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[124796226]
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). As the result matched (b)(6) serology results (abbott), the donation was released. A new sample collection was taken from this donor in (b)(6) 2018 and tested in a pool of 1 (pp1) with the cobas mpx test (lot currently unknown) as there was information that a recipient of the plasma sample from (b)(6) 2018 had developed an (b)(6) infection. Results of the new collection indicated that the donor sample was (b)(6) with late ct values. Serology results, tested with abbott, for the new draw were also (b)(6). No further information on the status of the recipient has been provided to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2018-00013 |
| MDR Report Key | 7996821 |
| Date Received | 2018-10-23 |
| Date of Report | 2018-10-23 |
| Date of Event | 2018-07-12 |
| Date Mfgr Received | 2018-09-28 |
| Date Added to Maude | 2018-10-23 |
| 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 SOUTH 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 | 2018-10-23 |
| Model Number | NA |
| Catalog Number | 06997716190 |
| Lot Number | 312109 |
| 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 | 2018-10-23 |