FDA 483 - iRhythm Technologies, Inc. - August 12, 2022

An FDA inspection of iRhythm Technologies, Inc. identified significant deficiencies in their quality system related to the Zio AT Cardiac Monitoring System. The firm failed to adequately establish corrective and preventive actions, resulting in delayed clinician notifications for life-threatening arrhythmias and a patient death. Additional issues included a failure to submit a Medical Device Report for the death, inadequate validation of manufacturing processes for re-used components, and improper handling of customer complaints.