Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Case Study #1

Device Assay for VIP (vasoactive intestinal polypeptide) for the detection of tumors in patients with chronic diarrheal diseases Event Low values for calibrators and kit controls with lot xyz leading to invalid results Potential outcome?

Reportable? An event occurred

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

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Case Study #1

Device Assay for VIP (vasoactive intestinal polypeptide) for the detection of tumors in patients with chronic diarrheal diseases Event Low values for calibrators and kit controls with lot xyz leading to invalid results

Action to be taken by user: Stop the use of lot xyz. A follow-up will be provided.

FSCA or FCA?

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