Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Case Study #2

Device sample processing system for high throughput clinical chemistry analyser Event Sample splashing requiring daily cleaning Potential clinical outcome?

Reportable? An event occurred

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

27

Case Study #2

Device sample processing system for high throughput clinical chemistry analyser Event Sample splashing requiring daily cleaning

Action to be taken by user: Follow your standard laboratory procedures to clean sample spills. Make sure to wear Personal Protective Equipment (PPE) while cleaning sample spills. A software update will be installed at your next scheduled maintenance

FSCA or FCA?

28

14