; or (B) 5 calendar days after an in vitro clinical test developer receives or otherwise becomes aware of information that reasonably suggests the event presents an imminent threat to public health. (2) Quarterly reports shall be submitted for all other adverse events, if any, and no later than the end of the quarter following the quarter in which the adverse event information was received by the in vitro clinical test developer. (d) Definitions In this section— (1) the term adverse event — (A) means— (i) death of, or serious injury to, a specific patient or user for which it is reasonably believed that an in vitro clinical test error contributed to such death or serious injury; or (ii) an in vitro clinical test error that may have reasonable likelihood to cause serious injury or death; and (B) excludes laboratory errors that are subject to the requirements of section 353 of the Public Health Service Act and corrective or preventive actions to prevent such errors; (2) the term in vitro clinical test error — (A) means a failure in an in vitro clinical test to meet the analytical or clinical validity standard or otherwise perform as intended by the developer; and (B) includes an inaccurate false result that reaches a health care provider, patient, or consumer, except that such term excludes any such event or error related to laboratory operations pursuant to section 353 of the Public Health Service Act; and (3) the term serious injury means— (A) a significant delay in a critical diagnosis or causing the absence, delay, or discontinuation of critical medical treatment or that irreversibly or seriously and negatively alters the course of the disease or condition; or (B) an injury that— (i) is life threatening; (ii) results in permanent impairment of a body function or permanent damage to a body structure