MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for COBAS? HBV 07000979190 manufactured by Roche Molecular Systems, Inc..
[138372632]
The investigation into the issue is on-going. The outcome of this investigation will be communicated via a follow-up report. The material number for the cap/ctm hbv test, v2. 0, ce-ivd is 04894570190. The udi for the cap/ctm hbv test, v2. 0, ce-ivd is (b)(4). The material number for the cobas hbv test, us-ivd is 07000979190. The udi for the cobas hbv test, us-ivd is (b)(4). The material number for the cap/ctm hbv test, v2. 0 us-ivd is 05027012190. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[138372633]
A customer from (b)(6) alleged result discrepancies for samples from a patient when tested with cobas hbv test for use with the cobas 6800/8800 system compared to the cap/ctm hbv test, v2. 0. The cobas hbv test generated consistently lower titers compared to the cap/ctm hbv test, v2. 0. The alleged patient sample was a part of the customer's validation study. No harm or injury was alleged in the complaint case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2019-00009 |
| MDR Report Key | 8394671 |
| Date Received | 2019-03-06 |
| Date of Report | 2019-05-08 |
| Date of Event | 2018-12-14 |
| Date Mfgr Received | 2019-02-12 |
| Date Added to Maude | 2019-03-06 |
| 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 |
| Manufacturer City | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COBAS? HBV |
| Generic Name | HEPATITIS VIRAL B DNA DETECTION |
| Product Code | MKT |
| Date Received | 2019-03-06 |
| Model Number | NA |
| Catalog Number | 07000979190 |
| Lot Number | E05129 |
| 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 | 2019-03-06 |