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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Wireless Communication Problem (3283)

Patient Problem Syncope/Fainting (4411)

Event Date 02/08/2022

Event Type  Injury  

Event Description

This mdr is being filed as the result of an update to our adverse event reporting procedure.The event occurred on (b)(6) 2022, but due to the new criteria, the awareness date is 29 dec 2022.

Manufacturer Narrative

On 11 feb 2022, a clinical operations manager reported there was a delayed mdn complication during the wear period and requested verification for any malfunction in transmitting on (b)(6) 2022.There was an event that occurred (b)(6) 2022 8:47 am est requiring mdn with transmission id (b)(6), but the transmission was delayed and received approximately 10 hours later for vt.Analysis of the gateway debug log revealed that the gateway experienced registration timeout logs due to poor cellular connections.Thus, gateway cell connections were delayed until good cellular reception was made available; attributing to the delayed episode transmission.The gateway was able to recover and continue normal operation clearing all backed up rpeaks through the server subsequently with last rpeak ackedid= 3282 (3282 is the last rpeak possible).No other performance or functional issues were found around the time of the alleged event nor the subsequent wear period.There is no indication there was any device malfunction (21 cfr 803) or ecg monitoring (42 cfr 410) deficiency that caused or contributed to this hospitalization.Loss of connectivity is a known inherent risk of the device.Zio at labeling contains the following warning: do not use the zio at on patients residing in areas with limited to no cellular reception.

• Brand Name: ZIO AT
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC; 699 8th st suite 600; san francisco 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: 16241126
• MDR Text Key: 308094752
• Report Number: 3007208829-2023-00008
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 06/22/2022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2021
• 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): Hospitalization
• Patient Age: 89 YR
• Patient Sex: Male