MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-10 for COBAS HCV TEST 06997732190 manufactured by Roche Molecular Systems.
[52662210]
The investigation into the case issue is currently on-going. A supplemental report will be provided at the end of the investigation. The common device name for this device is the following: assay, hybridization and/or nucleic acid amplification for detection of (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[52662211]
A patient was tested with the cobas (b)(4) test for use on the cobas 6800/8800 system. On (b)(6) 2016, a result of (b)(6) was generated. On (b)(6) 2016, a target not detected (tnd) result was generated. The tnd result was reproduced two additional times on (b)(6) 2016. The patient was previously diagnosed with (b)(6) and treatment information is not known.
Patient Sequence No: 1, Text Type: D, B5
[55250360]
A patient was tested with the cobas (b)(6) test for use on the cobas 6800/8800 system. On (b)(6) 2016, a result of 108 iu/ml was generated. On (b)(6) 2016, a target not detected (tnd) result was generated. The tnd result was reproduced two additional times on (b)(6) 2016. A retain kit from the alleged lot was tested during the course of the investigation and generated results met specifications, indicating no product malfunction. It was also confirmed that there was no harm as the first positive result was not reported out and the patient was already on treatment. Although requested, no serology test results could be provided for this patient. The four tested samples were collected from two separate blood draws. It remains unclear which blood draws generated the 3 "target not detected" results. As such, the issue is likely due to sample-specific and/or handling issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2016-00017 |
| MDR Report Key | 5866273 |
| Date Received | 2016-08-10 |
| Date of Report | 2016-08-26 |
| Date of Event | 2016-05-25 |
| Date Mfgr Received | 2016-07-11 |
| Device Manufacturer Date | 2016-02-19 |
| Date Added to Maude | 2016-08-10 |
| 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 VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537569 |
| 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 | 3 |
| Brand Name | COBAS HCV TEST |
| Generic Name | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR HCV |
| Product Code | MZP |
| Date Received | 2016-08-10 |
| Model Number | NA |
| Catalog Number | 06997732190 |
| Lot Number | 209570 |
| ID Number | NA |
| Device Expiration Date | 2017-07-31 |
| 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 |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-10 |