FDA Adverse Event
Malfunction
Summary report: N
UNICEL ¿ DXI 800 ACCESS ® IMMUNOASSAY SYSTEM
MDR report key: 2242297
·
Received September 10, 2011
Report
- Report Number
- 2122870-2011-03390
- Event Type
- Malfunction
- Date Received
- September 10, 2011
- Date of Event
- August 12, 2011
- Report Date
- August 12, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K023764
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON (B)(6) 2011, A BEC FIELD SERVICE ENGINEER (FSE) FOUND A LEAK IN THE WASTE TRANSFER PERI TUBING. FSE REPLACED THE TUBING AND VERIFIED SYSTEM PERFORMANCE TO PUBLISHED SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT. BEC INTERNAL IDENTIFICATION (B)(4).
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT A LIQUID WASTE LEAK FROM THE UNICEL DXI800 ACCESS IMMUNOASSAY ANALYZER. PER CUSTOMER, THE INSTRUMENT WASTES TO A DRAIN, BUT THE LEAK APPEARS TO BE COMING FROM THE PUMP DRAWER ABOVE THE LIQUID WASTE CONTAINERS. THE LEAK SPILLED OUTSIDE THE INSTRUMENT TO A POOL OF APPROXIMATELY 3FT IN DIAMETER. THE CUSTOMER WORE PERSONAL PROTECTIVE EQUIPMENT TO CLEAN THE SPILL. NO INJURY OR EXPOSURE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL ¿ DXI 800 ACCESS ® IMMUNOASSAY SYSTEM | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE | JJE | BECKMAN COULTER INC. | DXI 800 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |