FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 800 PRO SYNCHRON® SYSTEM
MDR report key: 2143676
·
Received June 29, 2011
Report
- Report Number
- 2050012-2011-02527
- Event Type
- Malfunction
- Date Received
- June 29, 2011
- Date of Event
- May 30, 2011
- Report Date
- May 31, 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
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SERVICE VISITED THE SITE ON (B)(4) 2011 AND REPORTED THAT THERE WAS NO LEAK FROM THE HYDRO COMPARTMENT. IT HAD LEAKED DOWN FROM THE REAGENT AND SAMPLE MIXER STATIONS. THE FIELD SERVICE ENGINEER (FSE) REPLACED BOTH MIXER INSERTS AND TUBE FITTINGS.
Description of Event or Problem · 1
A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) A LEAK IN HYDRO AREA OF UNICEL DXC 800 PRO SYNCHRON SYSTEM. THE CUSTOMER STATED IT APPEARED TO BE A VERY SLOW LEAK. 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® SYSTEM | DISCRETE PHOTOMETRIC CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER, INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |