FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® CX9 ALX CLINICAL SYSTEM
MDR report key: 2110785
·
Received June 1, 2011
Report
- Report Number
- 2050012-2011-02072
- Event Type
- Malfunction
- Date Received
- June 1, 2011
- Date of Event
- May 4, 2011
- Report Date
- May 4, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K950958
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BCI SENT THE CUSTOMER A REAGENT REPLACEMENT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THE WASH CONCENTRATE BOTTLE LEAKED ON THE SYNCHRON CX9 ALX INSTRUMENT. NO INJURY WAS REPORTED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® CX9 ALX CLINICAL SYSTEM | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | CX9 ALX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |