FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER
MDR report key: 2103280
·
Received May 26, 2011
Report
- Report Number
- 2050012-2011-01973
- Event Type
- Malfunction
- Date Received
- May 26, 2011
- Date of Event
- April 25, 2011
- Report Date
- April 25, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K060256
- 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 VISITED AND OBSERVED NO ISSUE.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT HARDWARE LEAK FAILURES. THE CUSTOMER WAS TROUBLESHOOTING THE INSTRUMENT FOR NON DRY CUVETTE BEFORE REAGENT INJECT AND REAGENT SUBSYSTEM MOTION ERRORS. PRIMARY TECHNICIAN LEFT THE LAB FOR A BREAK AND ANOTHER TECHNICIAN HOME THE SYSTEM WITHOUT PUTTING WASH STATION BACK ON. THE WASH STATION SPLASHED, HOWEVER, SINCE THE UPPER LID WAS DOWN DURING THE EVENT, NO ONE HAD CONTACT WITH FLUID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | DXC 600I | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |