FDA Adverse Event
Malfunction
Summary report: N
ANALYTICAL P MODULE
MDR report key: 1193375
·
Received October 7, 2008
Report
- Report Number
- 1823260-2008-07400
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 15, 2008
- Report Date
- October 7, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K953239
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
USER EXPERIENCED A WATER LEAK COMING FROM UNDERNEATH THE ANALYZER, ONTO THE FLOOR. NO PATIENTS WERE AFFECTED BY THE LEAK, AND OPERATOR WAS NOT HARMED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A GAUGE FOR THE GEAR PUMP WAS LEAKING, AND REPLACED GAUGES FOR THE WATER PRESSURE SYSTEM. PERFORMANCE TESTS WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANALYTICAL P MODULE | CLINICAL CHEMISTRY ANALYZER - JJE | JJE | ROCHE DIAGNOSTICS | P MODULE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |