FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM
MDR report key: 1813441
·
Received August 24, 2010
Report
- Report Number
- 2050012-2010-00602
- Event Type
- Malfunction
- Date Received
- August 24, 2010
- Date of Event
- August 2, 2010
- Report Date
- August 24, 2010
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K060256
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT.
Description of Event or Problem · 1
UNICEL CLOSED TUBE ALIQUOTTER (UTCA) PROBES LEAKED UPON INSTALLATION BY FIELD SERVICE IN THE UNICEL DXC 660I SYNCHRON ACCESS INSTRUMENT WHILE PERFORMING PREVENTIVE MAINTENANCE (PM). BOTH PROBES INSTALLED FROM PM KIT STARTED LEAKING FROM WHERE THE LEVEL SENSE WIRE CONNECTS TO THE PROBES. THE LEAKAGE (PM) FROM THE PROBE WOULD BE DILUTED WASH SOLUTION. NO RESULTS WERE AFFECTED, NO EXPOSURE OCCURRED. PATIENT RESULTS NOT APPLICABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | DXC 660I | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |