FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS
MDR report key: 2073481
·
Received May 1, 2011
Report
- Report Number
- 2050012-2011-01146
- Event Type
- Malfunction
- Date Received
- May 1, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 1, 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
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE INSPECTED THE INSTRUMENT AND FOUND MC MANIFOLD WAS LEAKING. THE FSE REPLACED THE MANIFOLD ON NEXT DAY. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED A LEAK UNDER THE MC SIDE OF THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. CUSTOMER WAS UNABLE TO PINPOINT SOURCE OF LEAK. NO INJURY WAS REPORTED ON THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | DXC 800 PRO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |