FDA Adverse Event
Malfunction
Summary report: N
COBAS 6000 C501 MODULE
MDR report key: 1231147
·
Received November 12, 2008
Report
- Report Number
- 1823260-2008-08346
- Event Type
- Malfunction
- Date Received
- November 12, 2008
- Date of Event
- October 29, 2008
- Report Date
- November 12, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K060373
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
USER RECEIVED A DISCREPANT BICARBONATE RESULT FOR ONE PT SAMPLE. INITIAL RESULT WAS 46 MMOL/L, REPEAT RESULT WAS 23 MMOL/L. ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SERVICE REP DETERMINED THERE WAS CONTAMINATION IN THE EXTERNAL WATER TANK AND CLEANED THE TANK, INCUBATOR BATH AND WINDOWS. HE ALSO NOTED HE REPLACED THE PHOTOMETER LAMP, REACTION CELLS AND REAGENT CASSETTE. HE ALSO INSPECTED THE RINSE MECHANISM AND REPLACED THE SQUEEGEES. PERFORMANCE TESTS WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COBAS 6000 C501 MODULE | CLINICAL CHEMISTRY ANALYZER - JJE | JJE | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |