Erroneous result

For IVDs, an incorrect result can harm a patient through the medical decisions it drives, so erroneous results are central to IVD vigilance. Results within the documented expected rate are handled through trend reporting, while unexpected ones are assessed as possible incidents.

An ‘erroneous result’ should be understood to include any incorrect (i.e. inadequate, inaccurate or imprecise) result or information provided by an IVD.

MDCG 2023-3 Rev.2, Question 9