FDA Adverse Event
Other
Summary report: N
ADVIA CENTAUR
MDR report key: 1221835
·
Received November 4, 2008
Report
- Report Number
- 2432235-2008-00129
- Event Type
- Other
- Date Received
- November 4, 2008
- Date of Event
- October 17, 2008
- Report Date
- October 21, 2008
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS
- Product Code
- MMI
- PMA / PMN Number
- K971418
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- 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 INDICATE THAT THE CAUSE FOR THE DISCREPANT TROPONIN RESULT WAS DUE TO THE MALFUNCTION OF THE ASPIRATE/WASH BLOCK. THE INSTRUMENT HAS BEEN REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
A DISCREPANT POSITIVE ADVIA CENTAUR TROPONIN ULTRA RESULT WAS OBTAINED ON A PT SAMPLE. THE SAMPLE WAS RETESTED AND THE TROPONIN ULTRA RESULT WAS NEGATIVE. PT TREATMENT WAS PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES, AS A RESULT OF THE DISCREPANT TROPONIN ULTRA RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVIA CENTAUR | IMMUNOASSAY SYSTEM | MMI | SIEMENS HEALTHCARE DIAGNOSTICS | ADVIA CENTAUR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |