Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Case Study #7

Device Blood bank information system Event Error in software update may cause issue of incompatible blood Potential clinical outcome?

Reportable? An event occurred

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

37

Case Study #7

Device Blood bank information system Event Error in software update may cause issue of incompatible blood

Action to be taken by user: Do not install software update

FSCA or FCA?

38

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