FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM
MDR report key: 2221886
·
Received August 24, 2011
Report
- Report Number
- 2050012-2011-04739
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- January 24, 2011
- Report Date
- January 24, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BEC CTS (CUSTOMER TECHNICAL SUPPORT) WORKED WITH THE CUSTOMER AND FOUND THE SAMPLE SYRINGE WOULD NOT TIGHTEN (THE SYRINGE BARREL TURNED 360° WITHOUT TIGHTENING). THE CUSTOMER REPLACED THE SAMPLE ROD AND REMOVED SYRINGE ASSY AND INSPECTED THREADS ON 3 WAY VALVE AND BARREL - NO PROBLEMS WERE NOTED. THE CUSTOMER INSTALLED SYRINGE AND IT TIGHTENED PROPERLY, CC SAMPLE PROBE WAS PRIMED 5 TIMES WITH NO LEAKS. (B)(4).
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE IN THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM WAS LEAKING ON THE REACTION WHEEL COVER. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | DXC 800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |