FDA Adverse Event
Malfunction
Summary report: N
COBAS INTEGRA 800
MDR report key: 1221492
·
Received November 5, 2008
Report
- Report Number
- 1823260-2008-08180
- Event Type
- Malfunction
- Date Received
- November 5, 2008
- Date of Event
- October 17, 2008
- Report Date
- November 5, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K951595
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
USER EXPERIENCED A LEAK FROM THE ANALYZER. NO PT SAMPLES WERE INVOLVED. NO OPERATORS WERE HARMED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE WATER SUPPLY INLET FITTING WAS BROKEN OFF AND REPLACED THE FITTING. PERFORMANCE TESTS WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COBAS INTEGRA 800 | CLINICAL CHEMISTRY ANALYZER - JJE | JJE | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |