FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS
MDR report key: 1982830
·
Received February 9, 2011
Report
- Report Number
- 2050012-2011-00340
- Event Type
- Malfunction
- Date Received
- February 9, 2011
- Date of Event
- January 13, 2011
- Report Date
- January 13, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
HOTLINE HAD THE CUSTOMER REPLACE THE BOTTLE OF REAGENT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT WASH CONCENTRATE II REAGENT BOTTLE WAS LEAKING IN THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. NO INJURY WAS REPORTED ON THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | DXC 600 PRO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |