FDA Adverse Event
Other
Summary report: N
IMMULITE 2000
MDR report key: 1315811
·
Received February 13, 2009
Report
- Report Number
- 2247117-2009-00007
- Event Type
- Other
- Date Received
- February 13, 2009
- Date of Event
- February 2, 2009
- Report Date
- February 2, 2009
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS
- Product Code
- DGC
- PMA / PMN Number
- K970227
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE OF THE DISCORDANT HCG RESULT WAS DUE TO THE OPERATOR MANUALLY ENTERING THE WRONG PT SAMPLE # WITH ANOTHER PT ON THE INSTRUMENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
A DISCORDANT HCG RESULT WAS OBTAINED ON A PT SAMPLE. THE SAMPLE WAS REPEATED AND THE CORRECT HCG RESULT WAS REPORTED. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCE AS A RESULT OF THE DISCORDANT HCG RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMMULITE 2000 | IMMUNO-ASSAY ANALYZER | DGC | SIEMENS HEALTHCARE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |