Testing of patient sample or reference material using manufacturer's device

Definition

The investigation employed relevant empirical testing of a patient sample or reference material using the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.

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
• XE9MYTesting of patient sample or reference material using reference method