FDA Adverse Event
Malfunction
Summary report: N
ADVIA CENTAUR XP CORTISOL (COR) ASSAY
MDR report key: 2584167
·
Received May 22, 2012
Report
- Report Number
- 1219913-2012-00217
- Event Type
- Malfunction
- Date Received
- May 22, 2012
- Date of Event
- March 7, 2012
- Report Date
- April 23, 2012
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS, INC.
- Product Code
- JFT
- PMA / PMN Number
- K962559
- Removal / Correction Number
- Z-1390-2012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
URGENT FIELD SAFETY NOTICE ((B)(4)) WAS PROVIDED TO THE CUSTOMER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEY DID NOT RECEIVE AN ADVIA CENTAUR XP CORTISOL URGENT FIELD SAFETY NOTICE ((B)(4)) THAT WAS DISTRIBUTED TO CUSTOMERS IN MARCH 2012. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVIA CENTAUR XP CORTISOL (COR) ASSAY | CORTISOL IMMUNOASSAY | JFT | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | N/A | 256 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |