SOCRA CCRP Practice Exam

What is the medical device equivalent of an SAE?

1. Calibrated Device Incident

2. Unanticipated Adverse Device Effect (UADE)

3. Predicted Device Dysfunction

4. Calibrated Device Effectiveness

The correct answer is: Unanticipated Adverse Device Effect (UADE)

An SAE stands for Serious Adverse Event, which is an incident, whether related to the device or not, that results in death, life-threatening injury, permanent impairment of a body function, or requires medical or surgical intervention to prevent serious harm. The medical device equivalent of this is a UADE, or Unanticipated Adverse Device Effect. This is an unexpected and unfavorable reaction caused by a medical device that may result in serious harm or death. A Calibrated Device Incident (A) refers to a malfunction or issue with a device that has been calibrated. Predicted Device Dysfunction (C) is a potential issue that has not yet occurred. Calibrated Device Effectiveness (D) is not an official medical device term and does not accurately describe an adverse event. Therefore, the most accurate and similar term to an SAE is a UADE (B).