FDA Adverse Event
Other
Summary report: N
ADVIA CENTAUR
MDR report key: 1082569
·
Received July 21, 2008
Report
- Report Number
- 2432235-2008-00085
- Event Type
- Other
- Date Received
- July 21, 2008
- Date of Event
- June 21, 2008
- Report Date
- June 24, 2008
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- JJE
- PMA / PMN Number
- K971418
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CAUSE FOR THE DISCORDANT RESULTS WAS DUE TO THE CUSTOMER NOT FOLLOWING THE PROPER PROCEDURE FOR REPLACING THE WASH 1 FLUID. AS A RESULT, THE WASH 1 RESERVOIR RAN EMPTY. THE CUSTOMER WAS ABLE TO RESOLVE THE TISSUE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
DISCORDANT RESULTS WERE OBTAINED FOR TROPONIN ULTRA AND BNP. AND THE RESULTS WERE REPORTED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA OR BNP RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVIA CENTAUR | IMMUNO-ASSAY ANALYZER | JJE | SIEMENS HEALTHCARE DIAGNOSTICS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |