FDA Adverse Event
Malfunction
Summary report: N
UNICEL ¿ DXI 800 ACCESS ® IMMUNOASSAY SYSTEM
MDR report key: 2152626
·
Received July 7, 2011
Report
- Report Number
- 2122870-2011-01975
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- June 8, 2011
- Report Date
- June 8, 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
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON (B)(4) 2011, A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED WASH BUFFER TUBING AND A LIQUID WASTE TUBING WITHIN THE FLUIDICS DRAWER. FSE PRIMED THE INSTRUMENT AND NO ISSUES WERE NOTED. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT OBSERVING A MINIMAL FLUID LEAK ONTO THE FLOOR UNDERNEATH THE UNICEL DXI800 ACCESS IMMUNOASSAY ANALYZER. THE CUSTOMER STOPPED THE INSTRUMENT FROM FURTHER SAMPLE PROCESSING. 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. | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |