FDA Adverse Event
Malfunction
Summary report: N
ADVIA CENTAUR CORTISOL (COR) ASSAY
MDR report key: 2494131
·
Received March 16, 2012
Report
- Report Number
- 1219913-2012-00130
- Event Type
- Malfunction
- Date Received
- March 16, 2012
- Date of Event
- May 17, 2011
- Report Date
- May 17, 2011
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS, INC.
- Product Code
- JFT
- PMA / PMN Number
- K962559
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
SIEMENS HAS INVESTIGATED AND CONFIRMED THE CUSTOMER'S OBSERVATION OF REAGENT PACK SOLID PHASE BANDING (STREAKING) THAT AFFECTS THE ONBOARD STABILITY OF THE REAGENTS WHICH HAS THE POTENTIAL TO AFFECT BOTH CONTROLS AND PATIENT RESULTS OVER THE ONBOARD STABILITY PERIOD. AN URGENT FIELD SAFETY NOTICE ((B)(4)) WAS DISTRIBUTED TO CUSTOMERS IN (B)(6) 2012 TO ADDRESS THIS ISSUE.
Description of Event or Problem · 1
THE CUSTOMER HAS VISUALLY OBSERVED STREAKING EFFECTS OF THE SOLID PHASE PARTICLES IN THE ADVIA CENTAUR CORTISOL REAGENT READY PACKS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE VISUAL DISCORDANT CORTISOL REAGENT READY PACKS.
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 | 253 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |