FDA Adverse Event
Malfunction
Summary report: N
MOSAIQ
MDR report key: 3190673
·
Received June 24, 2013
Report
- Report Number
- 2950347-2013-00002
- Event Type
- Malfunction
- Date Received
- June 24, 2013
- Date of Event
- June 30, 2013
- Report Date
- June 24, 2013
- Manufacturer
- IMPAC MEDICAL SYSTEMS, INC.
- Product Code
- IYE
- PMA / PMN Number
- K123230
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PRESCRIPTION "FREQUENCY" IS NOT THE SAME AS ENTERED IN THE TWO SCENARIOS BELOW: ASSIGN PACK UP TYPE ORDER WITH FREQUENCY TO PT. ASSIGN CARE PLAN CONTAINING PICK UP TYPE ORDER SET WITH FREQUENCY TO PT. THERE WAS NO PT INVOLVED AT THE TIME OF THE EVENT. NO FURTHER INFO WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 286688 | MOSAIQ | ONCOLOGY INFO SYSTEM (IYE) | IYE | IMPAC MEDICAL SYSTEMS, INC. | 2.50.05D7 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |