FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
MDR report key: 2032166
·
Received March 29, 2011
Report
- Report Number
- 2050012-2011-00894
- Event Type
- Malfunction
- Date Received
- March 29, 2011
- Date of Event
- February 26, 2011
- Report Date
- February 26, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A BCI FIELD SERVICE ENGINEER (FSE) REPLACED A DEFECTIVE Y FITTING ON INSTRUMENT NO FOAM ASSEMBLY
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A NO FOAM LEAK AT THE Y CONNECTOR ON TOP OF THE BOTTLE. MINIMAL AMOUNT LEAKED OUTSIDE IN FRONT OF THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. PER CUSTOMER, THE CONNECTION FITTING HAS SPRAYED INSIDE HYDRO PNEUMATIC AREA DUE TO PRESSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER | CLINICAL CHEMISTRY ANALYZER, | JJE | BECKMAN COULTER INC. | DXC 600 PRO | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |