FDA Adverse Event
Malfunction
Summary report: N
COBAS INTEGRA 400
MDR report key: 1172472
·
Received September 19, 2008
Report
- Report Number
- 1823260-2008-07016
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- August 31, 2008
- Report Date
- September 19, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K951595
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
USER EXPERIENCED A LEAK FROM THE ANALYZER THAT WAS ALL OVER THE FLOOR AROUND THE ANALYZER. NO PATIENT SAMPLES WERE AFFECTED. ONE OPERATOR SLIPPED IN THE WATER, BUT WAS NOT HURT AND DID NOT FALL. THE FIELD SERVICE REPRESENTATIVE DETERMINED FLOAT SWITCH HAD FAILED AND REPLACED IT. PERFORMANCE TESTS WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COBAS INTEGRA 400 | CLINICAL CHEMISTRY ANALYZER - JJE | JJE | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |