FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
MDR report key: 2093995
·
Received May 18, 2011
Report
- Report Number
- 2122870-2011-01276
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Date of Event
- April 20, 2011
- Report Date
- April 20, 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
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER IS NOT QUESTIONING ASSAYS OR PATIENT RESULTS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE FOUND LEAKING LIQUID WASTE AND WASH BUFFER TRANSFER TUBING. THE FSE REPLACED LEAKING TUBING AND 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 BACK LEFT SIDE OF THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. PER CUSTOMER, THERE WAS NO EXPOSURE TO THE LEAKING FLUIDS. NO INJURIES WERE REPORTED BY THE CUSTOMER.
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 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |