Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

A reportable incident meets all three criteria

A: An event has occurred

•Results outside the declared performance of the test •A failure of a device to perform according to the intended purpose •Deficiency in the labelling, instructions for use or promotional materials.

B: The device is suspected to be a contributory cause

•manufacturers should err on the side of caution.

C: The event led, or might have led, to one of the following outcomes:

•death of a patient, user or other person •serious deterioration in state of health of a patient, user or other person. •(Includes indirect harm)

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XML or PDF Section 1: Administrative information Section 2: Medical device information Section 3: Incident information derived from healthcare professional/

facility/ patient/ lay user/ other Section 4: Manufacturer analysis Section 5: General comments Coded summary of report

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