FDA Adverse Event
Malfunction
Summary report: N
UNICEL® CLOSED TUBE ALIQUOTTER (UCTA) UNIT
MDR report key: 1960479
·
Received January 13, 2011
Report
- Report Number
- 2050012-2011-00033
- Event Type
- Malfunction
- Date Received
- January 13, 2011
- Date of Event
- December 12, 2010
- Report Date
- December 12, 2010
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE SYRINGE.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE LEFT WASH PUMP WAS LEAKING IN THE UNICEL CLOSED TUBE ALIQUOTTER (UCTA) UNIT. NO INJURY WAS REPORTED FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® CLOSED TUBE ALIQUOTTER (UCTA) UNIT | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |