FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER
MDR report key: 2160891
·
Received July 13, 2011
Report
- Report Number
- 2050012-2011-02994
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- June 11, 2011
- Report Date
- June 11, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K060256
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON (B)(6) 2011, A BEC FIELD SERVICE ENGINEER FOUND THE WASH SYRINGE WAS BROKEN. FSE PERFORMED PMC PER CHECKLIST AND INSTALLED NEW WASH SYRINGE.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT ON A BROKEN WASH SYRINGE ON THE UCTA THAT LEAKED WHILE CHANGING THE WASH BUFFER SUPPLY. THE CUSTOMER WORE A PPE AND USED ABSORBENT MATERIALS TO CLEAN THE SPILL. NO INJURY OR EXPOSURE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE. | JJE | BECKMAN COULTER INC. | DXC 600I | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |