FDA Adverse Event
Malfunction
Summary report: N
ADVIA CENTAUR CORTISOL (COR) ASSAY
MDR report key: 2559394
·
Received May 4, 2012
Report
- Report Number
- 1219913-2012-00186
- Event Type
- Malfunction
- Date Received
- May 4, 2012
- Date of Event
- March 7, 2012
- Report Date
- April 6, 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
- MO, 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 A ADVIA CENTAUR 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 CORTISOL (COR) ASSAY | CORTISOL IMMUNOASSAY | JFT | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | N/A | 257 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |