FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM
MDR report key: 2242483
·
Received September 10, 2011
Report
- Report Number
- 2050012-2011-05053
- Event Type
- Malfunction
- Date Received
- September 10, 2011
- Date of Event
- August 16, 2011
- Report Date
- August 16, 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
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER TECHNICAL SUPPORT (CTS) HAD THE CUSTOMER TIGHTEN THE CANISTER. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT CANISTER WASTE SUMP EXIT ON UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM WAS LEAKING BETWEEN CANISTER AND LID. 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 600 SYNCHRON® CLINICAL SYSTEM | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | JJE | BECKMAN COULTER, INC. | DXC 600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |