FDA Adverse Event
Other
Summary report: N
IMMULITE 2000
MDR report key: 1416717
·
Received May 15, 2009
Report
- Report Number
- 2247117-2009-00017
- Event Type
- Other
- Date Received
- May 15, 2009
- Date of Event
- April 20, 2009
- Report Date
- April 20, 2009
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- DGC
- PMA / PMN Number
- K970227
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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 INDICATES THAT THE CAUSE OF THE DISCORDANT PSA RESULT WAS DUE TO THE REAGENT LEVEL SENSE ERROR. THE CAUSE OF THE REAGENT LEVEL SENSE ERROR IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
DISCORDANT PSA RESULT WAS OBTAINED ON A PT SAMPLE, GENERATED ON IMMULITE 2000. THE SAMPLE WAS REPEATED AND THE RESULT WAS REPORTED. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT PSA RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMMULITE 2000 | IMMUNO-ASSAY ANALYZER | DGC | SIEMENS HEALTHCARE DIAGNOSTICS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |