MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO AT; DETECTOR AND ALARM, ARRHYTHMIA

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Type  Death  

Manufacturer Narrative

As of the time of the patient¿s passing, the at device was not sent back for evaluation.For transparency, the company also received a general inquiry from the patient regarding the gateway during the wear period.Customer care identified a potential registration discrepancy and created a support ticket to verify with the hcp location whether the device was accurately registered.A company representative was notified by the hcp location that the at device was registered to the wrong patient after the patient had passed away.Additional information about the cause of the patient¿s death was unavailable from the hcp location at the time, and the company representative was informed that the patient¿s family declined to discuss with the hcp location.The investigation also confirmed the at device reached the asymptomatic maximum transmission limit during the prescribed wear period.The company contacted the hcp representative, as well as the patient (incorrectly) identified in the physician order and notified them that the asymptomatic transmission limit was approaching.The company sent a replacement device to the patient identified in the physician order (registration) as wearing the device that was nearing the transmission limit.This report does not constitute an admission by irhythm that the product described in this report has any defects or has malfunctioned.Certain terms included in form fda 3500a and related mdr submission materials are fixed terms for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.H3 other text: single use device not returned.

Event Description

It was reported that the patient passed away while wearing the at device.After an investigation, it was confirmed that the physician order (i.E., registration) submitted to irhythm (the company) for the provision of ambulatory mct services with the at device contained an error.Specifically, the physician order containing the at device serial number identified the incorrect patient (i.E., it included incorrect patient information, such as name and date of birth).Consequently, medical doctor notifications (also referred to as event notifications or mdns) for arrhythmias of clinical interest during the product wear period were provided for the patient (incorrectly) identified by the provider.

• Brand Name: ZIO AT
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC; 699 8th st suite 600; CA 94103
• Manufacturer (Section G): IRHYTHM TECHNOLOGIES, INC; 6550 katella avenue, suite 200; cypress CA 90630
• Manufacturer Contact: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103
• MDR Report Key: 17936468
• MDR Text Key: 325674495
• Report Number: 3007208829-2023-00122
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/20/2024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Female