FDA Adverse Event
Other
Summary report: N
IMMULITE 2500
MDR report key: 1725682
·
Received June 10, 2010
Report
- Report Number
- 2247117-2010-00017
- Event Type
- Other
- Date Received
- June 10, 2010
- Date of Event
- May 17, 2010
- Report Date
- May 17, 2010
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS, INC.
- Product Code
- JJQ
- PMA / PMN Number
- K905215
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVAL. ANALYSIS OF THE INSTRUMENT AND THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN RESULTS CANNOT BE DETERMINED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
A DISCORDANT IMMULITE 2500 TROPONIN RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL RESULT DID NOT AGREE WITH THE PATIENT CLINICAL HISTORY. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMMULITE 2500 | IMMUNO-ASSAY | JJQ | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |