FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER
MDR report key: 1337168
·
Received March 10, 2009
Report
- Report Number
- 2050012-2009-00030
- Event Type
- Malfunction
- Date Received
- March 10, 2009
- Date of Event
- February 17, 2009
- Report Date
- March 10, 2009
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJC
- PMA / PMN Number
- K042291
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SERVICE WAS NOT APPLICABLE FOR THIS EVENT. CUSTOMER COVERED THE EDGE OF THE METAL PLATES AT THE OFFLOAD TRAY WITH TAPE.
Description of Event or Problem · 1
CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN INCIDENT THAT OCCURRED ON THE UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER. THE OPERATOR OF THE INSTRUMENT CUT HER FINGER ON THE OFFLOAD TRAY OF THE INSTRUMENT. SINCE THE OFFLOAD TRAY CONTAINS OFFLOADED SAMPLE RACKS, BIOHAZARD EXPOSURE IS POSSIBLE. PER CUSTOMER, THE OPERATOR REPORTED THIS AND GOT TREATED BY THE OCCUPATIONAL HEALTH DEPARTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER | CLINICAL CHEMISTRY ANALYZER | JJC | BECKMAN COULTER INC. | DXC 800 PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |