FDA Adverse Event
Malfunction
Summary report: N
UNICEL DXC 800 SYNCHRON SYSTEM
MDR report key: 2807601
·
Received October 29, 2012
Report
- Report Number
- 2050012-2012-01775
- Event Type
- Malfunction
- Date Received
- October 29, 2012
- Date of Event
- October 2, 2012
- Report Date
- October 3, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
RESULTS: FLOWCELL.
Description of Event or Problem · 1
CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 800 SYNCHRON SYSTEM GENERATED ERRONEOUS RESULTS FOR TWO PATIENT SAMPLES. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) REPLACED ALL THE ION SELECTIVE ELECTRODE TUBINGS, THE MODULAR CHEMISTRIES (MC) SAMPLE SYRINGE, THE MC T-VALVE, AND THE CARBON BRIDGE. THE FSE ALSO CLEANED THE FLOWCELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL DXC 800 SYNCHRON SYSTEM | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | JJE | BECKMAN COULTER, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |