FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® LX20 ANALYZER W/O CAP PIERCER
MDR report key: 2120794
·
Received June 10, 2011
Report
- Report Number
- 2050012-2011-02197
- Event Type
- Malfunction
- Date Received
- June 10, 2011
- Date of Event
- May 13, 2011
- Report Date
- May 13, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND PERFORMED SERVICE ON THE INSTRUMENT. FSE DETERMINED THAT ONE VALVE APPEARED TO BE LEAKING. FSE REPLACED 2 VALVES AND PRIMED THE INSTRUMENT 10 TIMES TO OBSERVE FOR LEAKING. PER FSE, THE HYDRO REMAINED DRY WITH NO EVIDENCE OF LEAKING.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING FLUID WAS LEAKING FROM THE SYNCHRON LX20 ANALYZER. THE CUSTOMER THOUGHT IT MIGHT BE WASH BUFFER CONCENTRATE. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® LX20 ANALYZER W/O CAP PIERCER | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |