FDA Adverse Event
Malfunction
Summary report: N
MODULAR ANALYTICS CORE
MDR report key: 1140542
·
Received August 28, 2008
Report
- Report Number
- 1823260-2008-06523
- Event Type
- Malfunction
- Date Received
- August 28, 2008
- Date of Event
- August 7, 2008
- Report Date
- August 28, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K953239
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
USER REPORTS A WATER LEAK COMING FROM BACK OF ANALYZER, DUE TO WASTE LINE BECOMING DISCONNECTED FROM ANALYZER. NO INJURIES WERE REPORTED. NO PATIENT RESULTS WERE AFFECTED. THE FIELD SERVICE REPRESENTATIVE FOUND WASTE TUBING DISCONNECTED FROM BACK OF ANALYZER, AND RECONNECTED WASTE TUBING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MODULAR ANALYTICS CORE | CLINICAL CHEMISTRY ANALYZER - JJE | JJE | ROCHE DIAGNOSTICS | MODULAR CORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |