FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
MDR report key: 2030067
·
Received March 25, 2011
Report
- Report Number
- 2050012-2011-00855
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 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
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER DID NOT WANT SERVICE BUT ONLY WANTED THE VALVE REPLACEMENT. BCI FIELD SERVICE ENGINEER (FSE) WHO WAS ONSITE ON (B)(6) 2011 CONFIRMED THAT THE VALVE WAS REPLACED CORRECTLY AND THE INSTRUMENT WAS NO LONGER LEAKING.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A FLUID LEAK ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER STATED THAT CC SAMPLE SYRINGE WAS LEAKING FROM THE VALVE. THE CUSTOMER HAS EXPOSURE OR RISK MANAGEMENT PLAN IN PLACE AND THE CUSTOMER USED PPE TO CLEAN THE LEAK. THERE WAS NO EFFECT TO PATIENT OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM | CLINICAL CHEMSTRY ANALYZER | JJE | BECKMAN COULTER, INC. | DXC 800 PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |