FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM
MDR report key: 2110820
·
Received June 1, 2011
Report
- Report Number
- 2050012-2011-01951
- Event Type
- Malfunction
- Date Received
- June 1, 2011
- Date of Event
- May 4, 2011
- Report Date
- May 4, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K060256
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2011 AND CUSTOMER REPORTED THAT THEY FOUND TUBING WAS LOOSE AT CLOT DETECTOR. FSE LOOKED OVER MODULE AND DRIED THE WET AREAS UNDER CC SAMPLE PROBE COVERS.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE WAS LEAKING. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |