FDA Adverse Event
Other
Summary report: N
ADVIA CENTAUR XP TROPONIN ULTRA ASSAY
MDR report key: 1994424
·
Received February 2, 2011
Report
- Report Number
- 1219913-2011-00012
- Event Type
- Other
- Date Received
- February 2, 2011
- Date of Event
- January 5, 2011
- Report Date
- January 6, 2011
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- MMI
- PMA / PMN Number
- K053020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION: FSE DISPATCHED AND THE CONCLUSION WAS BLEACH CONTAMINATION.
Description of Event or Problem · 1
A FALS POSITIVE ADVIA CENTAUR XP TROPONIN ULTRA RESULT WAS OBTAINED FOR A PT SAMPLE. THE RESULT WAS QUESTIONED. TESTING WAS REPEATED FOR THE PT SAMPLE ON A SECOND INSTRUMENT. THE RESULT WAS NEGATIVE. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVIA CENTAUR XP TROPONIN ULTRA ASSAY | TROPONIN IMMUNOASSAY | MMI | SIEMENS HEALTHCARE DIAGNOSTICS INC. | NA | 049 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |