FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON LX® I 725 CLINICAL SYSTEM
MDR report key: 2022818
·
Received March 17, 2011
Report
- Report Number
- 2050012-2011-00718
- Event Type
- Malfunction
- Date Received
- March 17, 2011
- Date of Event
- February 16, 2011
- Report Date
- February 16, 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
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BCI HOTLINE SENT THE CUSTOMER A REPLACEMENT VALVE AND SYRINGE TIP.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A LEAK ON SYNCHRON LX I 725 CLINICAL SYSTEM. THE LEAK WAS FROM VALVE AND SYRINGE ON CTA (CLOSED TUBE ALIQUOTTER) UNIT. NO INJURY WAS REPORTED, AND THERE WAS NO EFFECT TO PATIENT OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON LX® I 725 CLINICAL SYSTEM | CLINICAL CHEMSTRY ANALYZER | JJE | BECKMAN COULTER, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |