FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
MDR report key: 2071266
·
Received April 27, 2011
Report
- Report Number
- 2050012-2011-01319
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- March 28, 2011
- Report Date
- March 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE INLET DI WATER VALVE AND RESERVOIR FLOAT SWITCH. THE FSE VERIFIED OPERATION.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT A CANNISTER OVERFLOWED AND SPILLED LIQUID ONTO THE FLOOR FROM THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. CUSTOMER DID NOT KNOW WHICH CANNISTER OVERFLOWED. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED IN THIS EVENT.
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 |