FDA Adverse Event
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER
MDR report key: 1850658
·
Received October 1, 2010
Report
- Report Number
- 2050012-2010-00914
- Date Received
- October 1, 2010
- Date of Event
- September 4, 2010
- Report Date
- October 1, 2010
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER TECHNICAL SUPPORT (CTS) RECOMMENDED THE USE OF PERSONAL PROTECTIVE EQUIPMENT TO CLEAN THE SPILL. THE CUSTOMER CLEANED THE SPILL AND REPLACED THE LINE IN THE LABORATORY. SERVICE WAS NOT DISPATCHED.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO THE SYSTEM DRAIN LINE THAT LOOSENED FROM THE LABORATORY DRAIN AND LIQUID LEAKED OUT. NO CHEMICALS OR BIOHAZARDOUS MATERIAL WAS NOTED.
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. | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |