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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 10/27/2023

Event Type  Injury  

Event Description

During the patient's wear period, an arrhythmia was detected by the zio at device that met the requirements for medical doctor notification (mdn).The information was transmitted to irhythm¿s independent diagnostic testing facility (idtf) as expected.However, the investigation found that an error by the certified cardiographic technician (cct) resulted in the arrhythmia being misclassified.Upon discovery of the error, the healthcare provider (hcp) was immediately informed.Irhythm was made aware that the hcp would have consulted the patient for a pacemaker if the arrhythmia was known and that the patient had suffered a stroke.

Manufacturer Narrative

The at device was returned to irhythm, and a clinical report was successfully generated.The device's diagnostic data and logs indicate that no malfunctions were observed during the wear period.The misclassified arrhythmia was not caused by the algorithm, but rather by an error in interpretation by the certified cardiographic technician.This event is being reported per 21cfr 803 as an adverse event /serious injury.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.

• 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 Contact: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103
• MDR Report Key: 18190499
• MDR Text Key: 328780077
• Report Number: 3007208829-2023-00164
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 12/20/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2023
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2023
• 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): Life Threatening; Hospitalization
• Patient Age: 95 YR
• Patient Sex: Female