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

The FDA Form 483 details significant deficiencies at a facility manufacturing the Zio AT Cardiac Monitoring System, intended for near real-time cardiac event monitoring.

**Violations and Observations:**

1. **Inadequate Corrective and Preventive Action (CAPA) Procedures:** * **Device Limitation (Asymptomatic Transmission Threshold):** The Zio AT system has a maximum limit of (b)(4) asymptomatic transmissions. Since June 2019, 28 complaints reported severe patient episodes (e.g., Ventricular Tachycardia, Complete Heart Block, Asystole leading to death) that were not immediately reported to physicians due to this limit. For example, Complaint COMP-2021-6388 reported a patient death from Ventricular Tachycardia and Ventricular Fibrillation, where the prescribing account was not immediately notified. Another complaint (COMP-2022-2077) involved 32 minutes of sustained ventricular tachycardia with loss of consciousness, reported a week later. The firm has not implemented corrective actions despite being aware of this limitation since 2019. The device also provides no indication to the patient when this limit is reached, contradicting labeling. * **Incomplete Patient Registration:** (b)(4) ZioTickets (August 2017-August 2022) for Zio AT systems had data held in the ZES System and