FDA Adverse Event
Malfunction
Summary report: N
ELECSYS 2010 DISK
MDR report key: 1193368
·
Received October 7, 2008
Report
- Report Number
- 1823260-2008-07395
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 17, 2008
- Report Date
- October 7, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K961481
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
USER EXPERIENCED LEAK FROM THE BACK OF THE ANALYZER AND ONTO THE FLOOR. NO PATIENT RESULTS WERE AFFECTED AND NO OPERATORS WERE HARMED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE, BUT NOTED HE CLEANED UP THE INSTRUMENT. ON FOLLOW UP VISIT, HE REPLACED A BROKEN TUBE JOINT C AND TYGON TUBING. HE ALSO REPLACED UPPER DEAD POINT SENSOR ON THE SIPPER SYRINGE AND CLEANED THE MECHANISM. ON SECOND FOLLOW UP VISIT, HE DETERMINED THERE WAS LEAKING SIPPER WASTE TUBING AND REPLACED IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELECSYS 2010 DISK | IMMUNOCHEMISTRY ANALYZER - JJE | JJE | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |