" /> Problem Identified during Non-Clinical Procedure - CISMeF





Preferred Label : Problem Identified during Non-Clinical Procedure;

NCIt synonyms : No Patient Involvement;

NCIt definition : An adverse event occurred while a device was being used in a non-clinical setting and/or procedure and could not have any impact on a patient.;

Alternative definition : FDA: The adverse event occurred while the device was being used in a non-clinical setting and/or procedure and could not have any impact on a patient. E.g.1. an IVD gave a false reading when testing an External Quality Assessment (EQA) sample; E.g.2. a surgical device malfunctioned during cleaning and/or maintenance.;

FDA table : Patient Code (Appendix B);

NCI Metathesaurus CUI : CL1928843;

Codes from synonyms : 2645;

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25/05/2025


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