FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
MDR report key: 2123900
·
Received June 14, 2011
Report
- Report Number
- 2050012-2011-02287
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Date of Event
- May 17, 2011
- Report Date
- May 17, 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
A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE OBSERVED REAGENT PROBE VACUUM VALVE CORRODED, AND REPLACED THE VACUUM VALVE. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT FLUID WAS FOUND ON THE REAGENT CARTRIDGE AND THE REAGENT PROBE B IS LEAKING. CUSTOMER CHANGED THE REAGENT PROBE B OUT AND THE PROBE WAS STILL LEAKING. 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 SYSTEM | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | DXC 800 PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |