FDA Adverse Event
Other
Summary report: N
ADVIA CENTAUR TROPONIN ULTRA ASSAY
MDR report key: 938042
·
Received November 1, 2007
Report
- Report Number
- 2432235-2007-00040
- Event Type
- Other
- Date Received
- November 1, 2007
- Date of Event
- September 13, 2007
- Report Date
- September 24, 2007
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
- Product Code
- MMI
- PMA / PMN Number
- K053020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
SAMPLES FROM THIS PATIENT WERE REQUESTED AND INTERNAL INVESTIGATIONS INDICATED THE DISCREPANT RESULTS ARE DUE TO IMPROPER SAMPLE HANDLING. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.
Description of Event or Problem · 1
THREE SAMPLES FROM THE SAME PATIENT WERE TESTED USING THE TROPONIN ULTRA ASSAY ON THE ADVIA CENTAUR AND ALL 3 HAD ELEVATED DOSES. WHEN THE SAMPLES WERE DILUTED THEY WERE TESTED AS NEGATIVE. THE SAMPLES WERE RE-TESTED ON A DIFFERENT LOT OF THE TROPONIN ULTRA ASSAY AND ALL 3 SAMPLES TESTED POSITIVE AGAIN. THERE IS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVIA CENTAUR TROPONIN ULTRA ASSAY | TROPONIN IMMUNOASSAY | MMI | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS | NA | 120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |