FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON LX® DILUENT I
MDR report key: 2162977
·
Received July 15, 2011
Report
- Report Number
- 2050012-2011-02791
- Event Type
- Malfunction
- Date Received
- July 15, 2011
- Date of Event
- June 13, 2011
- Report Date
- June 13, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K965240
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
HOTLINE FAXED MATERIAL SAFETY DATA SHEET (MSDS) TO CUSTOMER.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC, (BEC) AND REPORTED THAT THEY LOADED A NEW DILUENT I REAGENT ON THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM, AND THE REAGENT LEAKED ON THE REAGENT WHEEL. THE CUSTOMER STATED THE LEAK WAS COMING FROM THE SEAMS AT THE BOTTOM OF THE CARTRIDGE. NO INJURY WAS REPORTED ON THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON LX® DILUENT I | DILUENT I | JJE | BECKMAN COULTER INC. | NA | M011794 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |