FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
MDR report key: 1975137
·
Received January 31, 2011
Report
- Report Number
- 2050012-2011-00285
- Event Type
- Malfunction
- Date Received
- January 31, 2011
- Date of Event
- January 7, 2011
- Report Date
- January 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FIELD SERVICE ENGINEER (FSE) SPOKE WITH THE CUSTOMER AND STATED THE SYSTEM DID NOT REQUIRE SERVICE. ON (B)(6) 2011 THE CUSTOMER REPORTED THE SAME ISSUE ON RECUR AND THE SYSTEM WAS RESUMED FOLLOWING THE SERVICE TASK. THE REOCCURRENCE IS DOCUMENTED AND REPORTED IN MED WATCH #2050012-2011-00318.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE REAGENT PROBE WAS SQUIRTING FLUID IN THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER NOTICED THE FLUID LEAK WHILE PERFORMING WEEKLY MAINTENANCE ON THE INSTRUMENT. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | DXC 600 PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |