Last updated on NOVEMBER 18, 2015
Applies to:Oracle Argus Safety - Version 7.0.3 and later
Information in this document applies to any platform.
In the MedWatch report, the Serious Injury check box in Box H1 'Type of Reportable Event' should always be ticked for a serious medical device case regardless of the seriousness criteria selected for the case. This is not happening correctly in Argus 7.0.3.
The current logic says: Serious Injury in Box H1 is checked if 'Hospitalised' or 'Life Threatening' is checked in the case.
It is not acceptable to select the 'Hospitalised' or 'Life Threatening' seriousness criteria in the case just to have Serious Injury checked in H1. This will also result in section B2 having incorrect/discrepant information.
How can the mapping be changed to check the Serious Injury check box in Box H1 for serious medical device cases?
Sign In with your My Oracle Support account
Don't have a My Oracle Support account? Click to get started
Million Knowledge Articles and hundreds of Community platforms