MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZEUS SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Device Problem Inaccurate Information (4051)

Patient Problem Atrial Flutter (1730)

Event Date 04/20/2023

Event Type  Injury  

Event Description

The patient experienced an arrhythmia that was not detected by the device¿s automatic detection feature and was subsequently not identified during the wear-period.

Manufacturer Narrative

The patient was prescribed a zio at device that was placed in clinic by their physician on (b)(6) 2023.The patch was worn by the patient for 14 days and was received at irhythm for processing on (b)(6) 2023.While compiling the final report, it was found that the patient experienced atrial flutter that was misclassified by the device¿s automatic detection feature.The account was notified of the misclassified event on (b)(6) 2023 and it was communicated that the patient presented to the er on (b)(6) 2023 with chest pain (cause unknown) and was noted the patient was in atrial flutter.Device diagnostic data indicates that no functional issues were observed during the wear period.Analysis of device logs found that the device performed as intended with no performance or functional issues noted.The leading cause of the misclassified arrhythmia is attributed to a potential algorithm sensitivity.It was determined that the algorithm should have detected atrial flutter.The account stated that the patient presented to the hospital in atrial flutter.Based on the available information, it is inconclusive whether or not the patient¿s hospitalization was related to the atrial flutter.

• Brand Name: ZEUS SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: 17106816
• MDR Text Key: 316956442
• Report Number: 3007208829-2023-00030
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222389
• 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: 05/17/2023

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: 09/19/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2023
• 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): Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male