FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER
MDR report key: 2182736
·
Received July 28, 2011
Report
- Report Number
- 2050012-2011-03865
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- July 1, 2011
- Report Date
- July 5, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K060256
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A BEC FIELD SERVICE ENGINEER (FSE) REMOVED AND DISASSEMBLED THE GRAVITY SUMP. FSE DID NOT NOTE ANY ISSUES WITH O-RING, FLOAT AND VALVE. FSE REPLACED THE FLOAT SWITCH AND PRIMED THOROUGHLY. SUMP IS DRAINING NORMALLY. (B)(4).
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT GRAVITY SUMP IS INTERMITTENTLY OVERFLOWING. NO INJURY OR EXPOSURE TO FLUID WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE. | JJE | BECKMAN COULTER INC. | DXC 600I | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |