FDA Adverse Event
Other
Summary report: N
STRATUS CS STAT FLUOROMETRIC ANALYZER
MDR report key: 1113383
·
Received August 8, 2008
Report
- Report Number
- 2517506-2008-00072
- Event Type
- Other
- Date Received
- August 8, 2008
- Report Date
- July 14, 2008
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS, INC.
- Product Code
- MMI
- PMA / PMN Number
- K051650
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
A FALSELY ELEVATED TROPONIN I RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED AND A NEGATIVE RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRATUS CS STAT FLUOROMETRIC ANALYZER | ACUTE CARE TROPONIN I TEST PAK | MMI | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | NA | 238119002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |