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

Device Problem Patient Data Problem (3197)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2023

Event Type  malfunction  

Manufacturer Narrative

A registration discrepancy between two patients resulted in one of the final reports initially being posted for the incorrect patient.No protected health information (phi) was disclosed to the incorrect party.The clinical reports were corrected and provided to the patient¿s healthcare provider.No adverse events occurred.Irhythm investigated the reported event and reviewed production records for the device.The investigation identified that a shipping error occurred which led to the registration discrepancy between the two patients.This event is being reported per 21cfr803 as a product problem/malfunction.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.

Event Description

A registration discrepancy between two patients resulted in one of the final reports initially being posted for the incorrect patient.No protected health information (phi)was disclosed to the incorrect party.The clinical reports were corrected and provided to the patient¿s healthcare provider.No adverse events occurred.

• Brand Name: ZIO XT
• Type of Device: 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: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 18474494
• MDR Text Key: 333092414
• Report Number: 3007208829-2024-00003
• Device Sequence Number: 1
• Product Code: DSH
• Combination Product (y/n): N
• PMA/PMN Number: K121319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/18/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2022
• 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 Age: 64 YR
• Patient Sex: Female