Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Case Study #6

Device SARS CoV antigen laboratory test Event False reactive results with specific swab type Potential clinical outcome?

Reportable? An event occurred

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

35

Case Study #6

Device SARS CoV antigen laboratory test Event False reactive results with specific swab type

Action to be taken by user: Transition to new swab type

FSCA or FCA?

36

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