MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC. ZIO XT; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number N/A

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

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 03/16/2021

Event Type  Injury  

Event Description

Subject no.(b)(6) was screened and randomized on (b)(6) 2021 for protocol (b)(4).Subject was randomized to zio xt monitor arm and the device was applied at the visit per protocol.Subject had no known allergies to any adhesive prior to the enrollment.After few hours, subject developed a rash and itchiness.Subject contacted irhythm customer care and they instructed him to remove and return the device.Fda safety report id # (b)(4).

• Brand Name: ZIO XT
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC.
• MDR Report Key: 11602734
• MDR Text Key: 243636405
• Report Number: MW5100481
• Device Sequence Number: 1
• Product Code: DQK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/30/2021
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR