FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® LX NO FOAM
MDR report key: 2023772
·
Received March 18, 2011
Report
- Report Number
- 2050012-2011-00779
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 14, 2011
- Report Date
- February 14, 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
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS EVENT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING A LEAKAGE THAT WAS CAUSED BY A BROKEN BOTTLE OF THE SYNCHRON LX NO FOAM REAGENT KIT. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® LX NO FOAM | GENERAL PURPOSE REAGENT | JJE | BECKMAN COULTER INC. | NA | M009418 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |