Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Case Study #5

Device SARS CoV antigen near patient test Event suspected false positive results in specific lots Potential clinical outcome?

Reportable? An event occurred

The device was a contributory cause The event could have led to harm

33

Case Study #5

Device SARS CoV antigen near patient test Event suspected false positive results in specific lots

Action to be taken by user: mandatory software update to ensure only valid Test Strips are used

FSCA or FCA?

34

17