FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
MDR report key: 2042782
·
Received April 7, 2011
Report
- Report Number
- 2050012-2011-00978
- Event Type
- Malfunction
- Date Received
- April 7, 2011
- Date of Event
- March 6, 2011
- Report Date
- March 6, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K060256
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE CUSTOMER AND THE LEAK HAD STOPPED. THE CUSTOMER COULD NOT TELL IF IT WAS WATER, NO FOAM OR SOMETHING ELSE. THE CUSTOMER IS TO MONITOR AND CALLBACK IF THE LEAK COMES BACK. THERE HAVE BEEN NO FURTHER COMPLAINTS REGARDING THIS ISSUE FROM THIS ACCOUNT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THERE WAS A LEAK FROM THE HYDRO AND THE SOURCE OF THE LEAK COULD NOT BE IDENTIFIED. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |