FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEMS
MDR report key: 2031586
·
Received March 28, 2011
Report
- Report Number
- 2050012-2011-00875
- Event Type
- Malfunction
- Date Received
- March 28, 2011
- Date of Event
- February 3, 2011
- Report Date
- February 27, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K060256
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FSE REPLACED MULTIPLE HARDWARE COMPONENTS. NO ADDITIONAL INFORMATION REGARDING THIS EVENT WAS SUPPLIED. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem · 1
WHILE INSPECTING THE UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEMS FOR A DIFFERENT ISSUE, A FIELD SERVICE ENGINEER (FSE) FOUND SIGNS OF OVERFLOW IN CUVETTE WASH TRAY. THE FSE OBSERVED A COMPLETE CUVETTE WASH CYCLE, BUT NO OVERFLOWING SEEN. NO INJURY HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEMS | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |