FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® CX5 DELTA CHEMISTRY ANALYZER
MDR report key: 1904774
·
Received November 22, 2010
Report
- Report Number
- 2050012-2010-01347
- Event Type
- Malfunction
- Date Received
- November 22, 2010
- Date of Event
- October 21, 2010
- Report Date
- November 18, 2010
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K881495
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE INSPECTED ISE, CHECKED DRAIN FUNCTION, AND FOUND THAT THE EIC WAS CLOGGED WITH GEL AND THE FSE CLEANED THE EIC. THE FSE ALSO PERFORMED FURTHER REPAIRS AND RECALIBRATED THE INSTRUMENT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING THE ELECTROLYTE INJECTION CUP (EIC) NOT DRAINING AND LEAKING INTO THE COMPARTMENT OF THE SYNCHRON CX5 DELTA CHEMISTRY ANALYZER. NO OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® CX5 DELTA CHEMISTRY ANALYZER | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | CX5 DELTA | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |