FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
MDR report key: 2110832
·
Received June 1, 2011
Report
- Report Number
- 2050012-2011-01963
- Event Type
- Malfunction
- Date Received
- June 1, 2011
- Date of Event
- May 5, 2011
- Report Date
- May 5, 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) WENT ON-SITE (B)(6) 2011 AND FOUND THAT THE WASH COLLAR VACUUM VALVE HAD FAILED AND REPLACED THE VALVE, PRIMED THE PROBE TO ASSURE VACUUM IS WORKING CORRECTLY.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THE MODULAR CHEMISTRY (MC) SAMPLE PROBE WAS LEAKING. PER CUSTOMER, SHE WAS UNABLE TO HEAR THE VACUUM SOUND COMING FROM THE COLLAR WASH THAT WOULD NORMALLY BE HEARD. THE CUSTOMER WAS NOT HARMED BY THE LEAK AND NO SAMPLES WERE CORRECTED BECAUSE THE RESULTS WERE SUPPRESSED.
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 |