Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Case Study #3

Device Test for the detection of chlamydia in urine or swab samples Event 5 samples negative with the assay but positive with another assay Potential clinical outcome?

Reportable? An event occurred

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

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Case Study #3

Device Test for the detection of chlamydia in urine or swab samples Event 5 samples negative with the assay but positive with another assay

Action to be taken by user: Continue to use test but retest specific negative results. Consider the need for retest of stored samples and patient recall. The assay will be redesigned.

FSCA or FCA?

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