FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® LX 20 PRO CLINICAL SYSTEMS
MDR report key: 2103129
·
Received May 25, 2011
Report
- Report Number
- 2050012-2011-01908
- Event Type
- Malfunction
- Date Received
- May 25, 2011
- Date of Event
- April 25, 2011
- Report Date
- April 25, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K011213
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BCI FIELD SERVICE ENGINEER (FSE) FOUND A LEAKING FILTER IN THE HYDRO AND REPLACED THE FILTER AND TUBING.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THEY FOUND A LEAK COMING FROM THE BACK OF THE SYNCHRON LX20 PRO CLINICAL ANALYZER. THE CUSTOMER DID NOT KNOW WHAT THE LIQUID WAS. EFFECT TO PATIENT OR USER WAS NOT REPORTED IN CONNECTION WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® LX 20 PRO CLINICAL SYSTEMS | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | LX 20 PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |