FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM
MDR report key: 2073500
·
Received May 2, 2011
Report
- Report Number
- 2122870-2011-01037
- 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
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO SYSTEM ERROR MESSAGES WERE NOTED FOR THIS EVENT. NO SYSTEM PERFORMANCE INFORMATION WAS PROVIDED BY CUSTOMER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE INSPECTED THE INSTRUMENT AND DISCOVERED LEAKING WASH BUFFER TRANSFER PERI-PUMP TUBING TO BE LEAKING. THE FSE REPLACED THE TUBING AND VERIFIED SYSTEM PERFORMANCE TO PUBLISHED SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) TO REPORT LEAKING FROM THE FRONT LEFT OF THE UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM. NO REPORT OF INJURY TO THE USER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |