FDA Adverse Event
Other
Summary report: N
VERSANT 440 HCV RNA 3.0 ASSAY (BDNA)
MDR report key: 3234085
·
Received July 16, 2013
Report
- Report Number
- 3003932969-2013-00003
- Event Type
- Other
- Date Received
- July 16, 2013
- Date of Event
- June 25, 2013
- Report Date
- July 12, 2013
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS
- Product Code
- MZP
- PMA / PMN Number
- P020022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.
Description of Event or Problem · 1
USING THE VERSANT HCV RNA 3.0 ASSAY (BDNA), TWO PT SAMPLES GAVE (B)(6) RESULTS. THESE VALUES WERE NOT REPORTED. THE RUNS WERE REPEATED AND THE RESULTS WERE (B)(6). THE ASSAY IS INTENDED AS AN AID IN THE MGMT OF (B)(6) PTS UNDERGOING ANTI-VIRAL THERAPY. NO CHANGE OF THERAPY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328793 | VERSANT 440 HCV RNA 3.0 ASSAY (BDNA) | VERSANT 440 HCV RNA 3.0 ASSAY (BDNA) | MZP | SIEMENS HEALTHCARE DIAGNOSTICS | C047 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |