FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® LX20 PRO CLINICAL SYSTEM
MDR report key: 2123901
·
Received June 14, 2011
Report
- Report Number
- 2050012-2011-02288
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Date of Event
- May 17, 2011
- Report Date
- May 17, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K965240
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE CUSTOMER LOADED SHORT SAMPLE AND PICKED UP SEVERE CLOT WHICH BROKE THE OBSTRUCTION DETECTOR DIAPHRAGM, JAMMED ELECTROLYTE INJECTION CUP (EIC), WASH COLLAR AND PROBE ON MODULAR CHEMISTRIES (MC) SIDE. THE FSE REPLACED PROBE, WASH COLLAR AND MC CLOT DETECTOR. THE FSE ALSO CLEANED EIC BLOCK PORTS AND RUN ALIGNMENTS. THE ISSUE WAS RESOLVED.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT PROBE ON SYNCHRON LX20 PRO CLINICAL SYSTEM WAS LEAKING FROM REAR OF THE PROBE. NO INJURY WAS REPORTED IN CONNECTION WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® LX20 PRO CLINICAL SYSTEM | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | LX20 PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |