FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM (PACKAGED)
MDR report key: 2042789
·
Received April 7, 2011
Report
- Report Number
- 2050012-2011-00983
- Event Type
- Malfunction
- Date Received
- April 7, 2011
- Date of Event
- March 7, 2011
- Report Date
- March 7, 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BCI CONTACTED THE CUSTOMER AND VERIFIED THAT THEIR ENGINEER REPLACED THE T-VALVE AND THIS RESOLVED THE ISSUE. NO SERVICE VISIT WAS NEEDED.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AFTER NOTICING A LEAK OF THE CARTRIDGE CHEMISTRY (CC) SAMPLE T-VALVE AND HAD THEIR ENGINEER REPLACE THE PART. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM (PACKAGED) | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | DXC 800 PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |