FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON LXI® 725 CLINICAL SYSTEM
MDR report key: 2240438
·
Received September 9, 2011
Report
- Report Number
- 2050012-2011-05050
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- August 11, 2011
- Report Date
- August 11, 2011
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JJE
- PMA / PMN Number
- K023049
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WASH CONCENTRATE SOLUTION LEAKED FROM THE OVERFILLED WASH CONCENTRATE RESERVOIR. BEC FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(6) 2011 AND RESOLVED THE ISSUE BY REPLACING VALVE V12. (B)(4).
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT A LEAK FROM SYNCHRON LXI 725 CLINICAL SYSTEM. NO ERRONEOUS PATIENT RESULT WAS GENERATED. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NO EFFECT TO PATIENT OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON LXI® 725 CLINICAL SYSTEM | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | JJE | BECKMAN COULTER, INC. | LXI 725 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |