Historical data analysis

Definition

The investigation involved the analysis of historical adverse events data of the actual device involved in the adverse event and/or of products from the same and/or different batches/lots.

Also indexed as

Nearby in Cause investigation and type of investigation

• XE9HDTesting of actual or suspected device
• XE7XHTesting of device from same lot or batch retained by manufacturer
• XE4S0Testing of device from same lot batch returned from user
• XE2ZRTesting of device from other lot batch retained by manufacturer
• XE4X1Testing of device from other lot or batch returned from user
• XE1XTTesting of model variant
• XE8XVTesting of raw or starting materials
• XE6FSTesting of patient sample or reference material using manufacturer's device