FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER
MDR report key: 2140235
·
Received June 26, 2011
Report
- Report Number
- 2050012-2011-02642
- Event Type
- Malfunction
- Date Received
- June 26, 2011
- Date of Event
- May 26, 2011
- Report Date
- May 26, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON (B)(4) 2011, A BCI FIELD SERVICE ENGINEER (FES) POWERED UP THE INSTRUMENT AND PRIMED ALL LINES. NO SMELL WAS DETECTED. FSE RELOADED ALL REAGENTS AND RAN QC. FSE WAS UNABLE TO REPRODUCE THE ISSUE.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) HOTLINE IN REGARDS TO A BURNING SMELL COMING FROM THE BACK OF THE INSTRUMENT. THE HOTLINE INFORMED THE CUSTOMER TO SHUTDOWN THE INSTRUMENT. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | DXC 600 PRO | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |