FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS
MDR report key: 1970770
·
Received January 25, 2011
Report
- Report Number
- 2050012-2011-00229
- Event Type
- Malfunction
- Date Received
- January 25, 2011
- Date of Event
- January 2, 2011
- Report Date
- January 2, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON (B)(4) 2011, A BCI FIELD SERVICE ENGINEER (FSE) REPLACED REAGENT PROBE B VACUUM VALVE. THE ISSUE HAS BEEN RESOLVED.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO REAGENT PROBE LEAKING INTO A TRAY AND ON TOP OF THE REAGENT CARTRIDGE. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | DXC 800 PRO | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |