FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER
MDR report key: 2221136
·
Received August 23, 2011
Report
- Report Number
- 2050012-2011-04719
- Event Type
- Malfunction
- Date Received
- August 23, 2011
- Date of Event
- March 10, 2011
- Report Date
- March 10, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 AND LOCATED THE LEAK FROM THE MC SAMPLE SYRINGE T-VALVE. THE FSE REPLACED THE VALVE. NO FURTHER LEAKING WAS REPORTED FOLLOWING THE REPAIRS. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE MODULAR CHEMISTRY (MC) SAMPLE SYRINGE 3-WAY VALVE WAS "CRACKED" AND LEAKING IN THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER OBSERVED THE 3-WAY VALVE WAS "CRACKED" WHEN THEY CHANGED THE SAMPLE SYRINGE PLUNGER TO TROUBLESHOOT THE LEAKING. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED IN THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | DXC 800 PRO | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |