FDA Adverse Event
Summary report: N
ADVIA CENTAUR XP B-TYPE NATRIURETIC PEPTIDE (BNP)
MDR report key: 4122979
·
Received September 2, 2014
Report
- Report Number
- 4122979
- Date Received
- September 2, 2014
- Date of Event
- August 30, 2014
- Report Date
- September 2, 2014
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS, INC.
- Product Code
- NBC
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
EVERYTHING ABOUT THIS BOX SAYS BNP, INCLUDING THE PACKAGE INSERT AND END CAP ON THE CARTRIDGE, BUT IF YOU LOOK AT THE SIDE OF THE CARTRIDGE ITSELF IT SAYS FT4 (FREE T 4). THE CALIBRATION WORKED, BUT THE CONTROLS DID NOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 532505 | ADVIA CENTAUR XP B-TYPE NATRIURETIC PEPTIDE (BNP) | BNP IMMUNOASSAY | NBC | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | * | 43278174 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |