FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® CX9 ALX CLINICAL SYSTEM
MDR report key: 1964443
·
Received January 19, 2011
Report
- Report Number
- 2050012-2011-00141
- Event Type
- Malfunction
- Date Received
- January 19, 2011
- Date of Event
- December 23, 2010
- Report Date
- December 23, 2010
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K950958
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER TECHNICAL SUPPORT ASSISTED THE CUSTOMER WITH TROUBLESHOOTING (TS) AND DETERMINED THAT THE CAP WAS NOT TIGHTLY FASTENED AFTER THE BOTTLE WAS REFILLED. THE CUSTOMER TIGHTENED THE BOTTLE AND THE ISSUE WAS RESOLVED. THE SYSTEM IS NOW OPERATING ACCEPTABLY.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE REAGENT PROBE RINSE BOTTLE WAS LEAKING IN THE SYNCHRON CX9 ALX CLINICAL SYSTEM. NO OPERATOR EXPOSURE WAS NOTED.
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 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |