MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO XT; RECORDER, MAGNETIC TAPE, MEDICAL

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presented to their healthcare provider (hcp) with signs of skin irritation and allergic reaction allegedly caused by the zio xt.The patient experienced redness and blisters with broken skin.The device was removed and the patient was prescribed unknown antibiotics.
Additional Manufacturer Narrative
A review of the complaint revealed that the patient wore the zio xt device for 5 of the 14 days prescribed.The patient has sensitive skin but no known history of reactions to medical adhesives.The exact cause of the reported event cannot be determined; however, the patient¿s preexisting sensitivity cannot be ruled out as a contributory factor.Skin irritation and allergic reaction are known inherent risks of the device.The device manual warnings section read as follows: do not use the zio xt patch on patients with known allergic reaction to adhesives or hydrogels or with a family history of adhesive skin allergies.Patient may experience skin irritation.If skin irritation such as severe redness, itching or allergic symptoms develop, remove the zio xt patch from the patient¿s chest.This event is being reported per 21cfr803 as a serious injury.This report does not constitute an admission by rhythm 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.
Additional Manufacturer Narrative
This supplemental mdr is being submitted as a part of retrospective review from january 2021 till august 2025.A capa (2024-0036) was initiated on 29th september 2024 to implement corrective actions.Device performance and/or risk profile are not impacted.

• Brand Name: ZIO XT
• Common Device Name: RECORDER, MAGNETIC TAPE, MEDICAL
• 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: tara mackinnon ; 699 8th st suite 600; san francisco, CA 94103 ; 6094600577
• MDR Report Key: 22801016
• Report Number: 3007208829-2025-00058
• Device Sequence Number: 18344305
• Product Code: DSH
• UDI-Device Identifier: 00869770000203
• UDI-Public: (01)00869770000203(17)220110
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/10/2022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2021
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female