FDA Adverse Event
Malfunction
Summary report: N
STRATUS CS STAT FLUOROMETRIC ANALYZER
MDR report key: 1070531
·
Received July 2, 2008
Report
- Report Number
- 2517506-2008-00061
- Event Type
- Malfunction
- Date Received
- July 2, 2008
- Date of Event
- June 15, 2008
- Report Date
- June 17, 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
- FL, 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 RESULTS WAS NON SPECIFIC BINDING INTERFERENCE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
THREE FALSELY ELEVATED TROPONIN I RESULTS WERE OBTAINED ON A PT'S SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED AND NEGATIVE RESULTS WERE OBTAINED. THE PT WAS ADMITTED AND GIVEN A STRESS TEST. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULTS.
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 | 238126002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 94 YR |