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

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2022

Event Type  Death  

Manufacturer Narrative

This mdr submission represents an incident where the patient expired.The investigation revealed the device was applied on (b)(6) 2022, but the gateway was never activated so no data could be transmitted.An attempt to contact the patient was made on (b)(6) 2022 to rectify why no baseline transmission had been received.Contact was made, but for the wrong patient due to a registration error at the account.The account was notified the same day.Not until (b)(6) 2022 did the account notify of the patient¿s death at which time we informed the account again of the patient mix up and no gateway activation.The patient passed away on (b)(6) 2022.The device was returned on 12feb2022, at which time the stored data was analyzed.A review of the logs indicates the gateway was activated on (b)(6) 2022, at which time stored transmissions were sent showing a baseline transmission on (b)(6) 2022.

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 27dec2022.

• 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 ; 9494132147
• MDR Report Key: 16241125
• MDR Text Key: 308095775
• Report Number: 3007208829-2023-00007
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 07/18/2022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2022
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2022
• 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 Age: 69 YR
• Patient Sex: Female