FDA Adverse Event
Malfunction
Summary report: N
AU600 CHEMISTRY ANALYZER
MDR report key: 1831489
·
Received September 10, 2010
Report
- Report Number
- 2050012-2010-00724
- Event Type
- Malfunction
- Date Received
- September 10, 2010
- Date of Event
- August 26, 2010
- Report Date
- September 10, 2010
- Manufacturer
- BECKMAN COULTER MISHIMA K.K.
- Product Code
- JJE
- PMA / PMN Number
- K961274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER POWERED THE UNIT OFF UPON NOTICING THE SMOKE. A BCI FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE SMOKE AND CONCLUDED THAT THE CPU OF AU600 PC TO BE DEFECTIVE. FSE INSTALLED NEW COMPUTER, CLEANED CUVETTE, CALIBRATED AND QC TESTED THE UNIT. FSE VERIFIED ALL REPAIRS PER ESTABLISHED PROCEDURES AND ALL RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO SMOKE BEING RELEASED FROM THE AU600 CHEMISTRY ANALYZER. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AU600 CHEMISTRY ANALYZER | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER MISHIMA K.K. | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |