The at device was returned to irhythm, and the clinical data was downloaded.A review of the clinical data found that the patient wore the at device for 2 days of the 7-day prescribed wear period.Irhythm became aware of the arrhythmia while preparing final report and notified the hcp on day 19.The investigation revealed that the gateway experienced multiple errors and the cell modem became unresponsive to ping commands, which led to the missed mdn.This event is being reported per 21cfr 803 as an product problem /malfunction.This report does not constitute an admission by irhythm that the product described in this report has any defects or has malfunctioned.These terms are included in form fda 3500a and are fixed terms for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.
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The patient experienced an arrhythmia that met medical doctor notification (mdn) requirements that was not transmitted during the wear period.The investigation revealed that the gateway experienced multiple errors and the cell modem became unresponsive to ping commands.The healthcare provider (hcp) was notified immediately, and irhythm learned that the hcp was already aware of the patient's arrhythmia and was treating it.No adverse events, such as death or serious injury, are known to have occurred.
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