FDA Adverse Event
Summary report: N
UNICEL® DXC 800 SYNCHRON ® CHEMISTRY ANALYZER
MDR report key: 1886546
·
Received October 29, 2010
Report
- Report Number
- 2050012-2010-01119
- Date Received
- October 29, 2010
- Date of Event
- October 11, 2010
- Report Date
- October 29, 2010
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE SAMPLE PROBE AND SYRINGE AND PERFORMED PREVENTIVE MAINTENANCE.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS CARTRIDGE CHEMISTRY (CC) PROBE LEAK AS WELL AS INCONSISTENT QC READING. NO INJURY AND/OR PERSONNEL EXPOSURE TO CHEMICAL OR BIO-HAZARDOUS MATERIAL WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 800 SYNCHRON ® CHEMISTRY ANALYZER | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |