FDA Adverse Event
Malfunction
Summary report: N
CELL-DYN SMS
MDR report key: 1590293
·
Received January 29, 2010
Report
- Report Number
- 2919069-2010-00019
- Event Type
- Malfunction
- Date Received
- January 29, 2010
- Date of Event
- January 9, 2010
- Report Date
- January 9, 2010
- Manufacturer
- ABBOTT DIAGNOSTICS DIVISION/CELLDYN
- Product Code
- GKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. OTHER TEXT : AN INVESTIGATION IS IN PROCESS
Description of Event or Problem · 1
THE CUSTOMER OBSERVED SMOKE COMING FROM THE CELL-DYN SMS. THE INSTRUMENT AND POWER SUPPLY WERE TURNED OFF. NO INJURY WAS REPORTED DUE TO THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CELL-DYN SMS | AUTOMATED BLOOD FILM PREPARATION AND STAINING | GKJ | ABBOTT DIAGNOSTICS DIVISION/CELLDYN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |