FDA 483 - iRhythm Technologies Inc - July 31, 2024

An FDA inspection of iRhythm Technologies Inc., conducted from July 15-31, 2024, revealed significant deficiencies in their quality system. The primary issues identified involved inadequate corrective and preventive action (CAPA) procedures, insufficient risk analysis, and a failure to submit required Medical Device Reports (MDRs) in a timely manner. Specifically, the company did not adequately analyze over 4,000 complaints concerning Certified Cardiographic Technician (CCT) personnel misinterpreting arrhythmia data, nor did they initiate appropriate investigations or health hazard evaluations. A breached algorithm sensitivity for Atrial Fibrillation detection and a persistent increase in skin irritation complaints also went unaddressed by robust CAPA measures. Furthermore, risk analyses for their Zio AT, Zio XT, Zio Monitor, and Zeus System Software medical devices were found to be incomplete, particularly regarding CCT operations and the inclusion of all relevant data for algorithm performance monitoring. Critically, iRhythm Technologies routinely failed to report device malfunctions, including those from CCT misinterpretations and algorithm errors, which had the potential to contribute to serious injury or death, as mandated by 21 CFR § 803. To achieve compliance, iRhythm Technologies must implement comprehensive corrective actions. These actions must ensure effective CAPA processes, thorough risk management, and timely, accurate adverse event reporting for their medical devices.