FDA Adverse Event
Malfunction
Summary report: N
COBAS INTEGRA 400 PLUS
MDR report key: 1191584
·
Received October 1, 2008
Report
- Report Number
- 1823260-2008-07297
- Event Type
- Malfunction
- Date Received
- October 1, 2008
- Date of Event
- September 9, 2008
- Report Date
- October 1, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K951595
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
USER REPORTS THE WASTE CONTAINER OVERFLOWED, WHICH LEAKED FLUID ONTO THE FLOOR. NO PATIENT SAMPLES WERE AFFECTED, AND NO ONE WAS HARMED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A FAULTY SENSOR ON WASTE CONTAINER AND REPLACED SENSOR. PERFORMANCE TESTS WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COBAS INTEGRA 400 PLUS | CLINICAL CHEMISTRY ANALYZER - JJE | JJE | ROCHE DIAGNOSTICS | I400+ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |