FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
MDR report key: 2242620
·
Received September 10, 2011
Report
- Report Number
- 2050012-2011-05058
- Event Type
- Malfunction
- Date Received
- September 10, 2011
- Date of Event
- August 12, 2011
- Report Date
- August 12, 2011
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SERVICE VISITED ON (B)(4) 2011 AND REPLACED THE NO FOAM BOTTLE AS IT WAS LEAKING. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT NO FOAM BOTTLE ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM HAD BEEN LEAKING FOR THE PAST FEW DAYS. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NO EFFECT TO PATIENT OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | JJE | BECKMAN COULTER, INC. | DXC 800 PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |