FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® LX20 PRO ANALYZER
MDR report key: 2091522
·
Received May 17, 2011
Report
- Report Number
- 2050012-2011-01588
- Event Type
- Malfunction
- Date Received
- May 17, 2011
- Date of Event
- April 19, 2011
- Report Date
- April 19, 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
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER WAS UNABLE TO DETERMINE THE SOURCE OF THE LEAK. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND THAT TUBING ON THE VALVE WAS BROKEN AND REPLACED IT. FSE ALSO CHECKED OTHER VALVES AND REPLACED TUBINGS WHICH RESOLVED THE ISSUE.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A LEAK OBSERVED COMING FROM THE REAR LOWER SECTION OF THE SYNCHRON LX20 PRO ANALYZER. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® LX20 PRO ANALYZER | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |