FDA MedWatch 3500A Normal Related Questions

(Doc ID 2385100.1)

Last updated on APRIL 27, 2018

Applies to:

Oracle Argus Safety - Version 7.0.2 and later
Information in this document applies to any platform.

Goal

Question 1:

1. 7.0.3 TRM
FDA MedWatch 3500A Normal
Red Dot #33
Source:
case_product.DEVICE_CODE
case_product.DEVICE_TYPE.

Where are these found in Argus Database?
Where are these found In Argus UI?

Question 2:

Where are the LOVs for ‘Malfunction Type’ under ‘Device Information’ section configured in Argus?

Question 3:

Are the fields ‘Device Sub-component name’ and ‘Device Sub component lot #’ free text or LOV?

Console > Argus > Code Lists > Device Subcomponents

Products tab > Device sub-tab
Device Subcomponent Lot#

Question 4:

Table: case_medwatch_data
Field:
FDA_PAT_CD1
FDA_PAT_CD2
FDA_PAT_CD3
FDA_DEV_CD1
FDA_DEV_CD2
FDA_DEV_CD3

For MedWatch Block F10, how are the values populated?
From which fields in Argus UI?

Question 5:

Analysis tab > Medwatch sub-tab

Unable to enter FDA Codes

When trying to type any text values into the fields, system displays the message:
"The code you entered is not valid".
Seems like these are LOV fields.
Where are these LOV fields defined?
 

Solution

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