FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON® SYSTEM
MDR report key: 2143691
·
Received June 29, 2011
Report
- Report Number
- 2050012-2011-02526
- Event Type
- Malfunction
- Date Received
- June 29, 2011
- Date of Event
- May 31, 2011
- Report Date
- May 31, 2011
- Manufacturer
- BECKMAN COULTER, INC
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SERVICE VISITED ON (B)(6) 2011 AND DETERMINED THAT GRAVITY SUMP CANISTER IS LEAKING. THE FIELD SERVICE ENGINEER (FSE) BLEACHED GRAVITY SUMP WASTE LINES. NO FURTHER HYDRO WATER LEAK COMPLAINT HAD BEEN FILED AS OF (B)(6) 2011.
Description of Event or Problem · 1
A CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) A LEAK COMING UNDER THE INSTRUMENT. THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600 PRO SYNCHRON® SYSTEM | DISCRETE PHOTOMETRIC CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER, INC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |