FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
MDR report key: 2091510
·
Received May 17, 2011
Report
- Report Number
- 2050012-2011-01807
- Event Type
- Malfunction
- Date Received
- May 17, 2011
- Date of Event
- April 16, 2011
- Report Date
- April 16, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND EXAMINED THE INSTRUMENT AND DETERMINED THAT THE ELECTROLYTE INJECTION CUP (EIC) AND THE ISE DRAIN OVERFLOWED DUE TO NO VACUUM AT LINE #15. FURTHER INSPECTION REVEALED THAT LINE #15 WAS CRIMPED UNDER THE GLUCOSE MODULE. THE FSE RE-ROUTED THE TUBING AND VERIFIED REPAIR PER ESTABLISHED PROCEDURES.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT FLUID WAS LEAKING UNDER THE MODULAR CHEMISTRY (MC) COMPARTMENT IN THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER STATED THE OPERATOR WAS NOT WEARING GLOVES AND ACCIDENTALLY TOUCHED THE FLUID, WHICH WAS BELIEVED TO BE REAGENT OR WASTE. THE CUSTOMER WASHED HANDS WITH WATER AND DID NOT SEEK MEDICAL ATTENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | DXC 600 PRO | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |