FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER
MDR report key: 2032165
·
Received March 29, 2011
Report
- Report Number
- 2050012-2011-00893
- Event Type
- Malfunction
- Date Received
- March 29, 2011
- Date of Event
- February 28, 2011
- Report Date
- February 28, 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
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A BCI FIELD SERVICE ENGINEER (FSE) FOUND A CRACKED Y FITTING AND BLACK FITTING AT THE BOTTLE. FSE REPLACED WITH SIMILAR TUBING AND PLACED AN ORDER FOR CORRECT FITTING TO BE DELIVERED TO SITE FOR INSTALLATION. THIS MDR IS ASSOCIATED WITH MDR 2050012-2011-00823.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A HYDRO LEAK AND FLOODING IN THE HYDRO-PNEUMATIC COMPARTMENT. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER | CLINICAL CHEMISTRY ANALYZER, | JJE | BECKMAN COULTER INC. | DXC 800 PRO | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |