FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
MDR report key: 2143418
·
Received June 29, 2011
Report
- Report Number
- 2050012-2011-02520
- Event Type
- Malfunction
- Date Received
- June 29, 2011
- Date of Event
- May 30, 2011
- Report Date
- May 30, 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
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE REPLACED THE NO FOAM CONTAINER AND ADJUSTED THE BOTTLE SENSOR AND VERIFIED REPAIR PER ESTABLISHED PROCEDURES. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND REPORTED THAT THEY WERE EXPERIENCING A NO FOAM LEAK FROM THE TOP OF THE BOTTLE AND NO FOAM LEVEL WAS CONTINUOUSLY DROPPING BELOW 10%. THE ISSUE IS ASSOCIATED WITH THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. A CUSTOMER TECHNICAL SUPPORT (CTS) GENERATED A SERVICE REQUEST. 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 SYSTEM | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |