FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
MDR report key: 2073499
·
Received May 2, 2011
Report
- Report Number
- 2122870-2011-01038
- Event Type
- Malfunction
- Date Received
- May 2, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 1, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K023764
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO SYSTEM PERFORMANCE INFORMATION WAS PROVIDED BY THE CUSTOMER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND REPLACED LEAKING WASTE TRANSFER TUBING. THE FSE VERIFIED SYSTEM PERFORMANCE TO PUBLISHED SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.
Description of Event or Problem · 1
THE CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING A LEAK FROM THE FLUIDICS DRAWER IN UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THERE WAS NO REPORT OF INJURY TO LAB PERSONNEL AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |