FDA 483 - iRhythm Technologies Inc - July 31, 2024

iRhythm Technologies Inc. in San Francisco was inspected regarding its medical device manufacturing. The inspection revealed significant deficiencies in corrective and preventive action procedures, inadequate risk analysis for its cardiac monitoring devices, and a failure to submit required Medical Device Reports (MDRs) for malfunctions involving both CCT personnel misreads and algorithm errors. These issues indicate a systemic problem in identifying, investigating, and reporting quality problems that could lead to serious patient harm.