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

Device Problem Patient Data Problem (3197)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2022

Event Type  malfunction  

Event Description

A final ecg report was provided to the physician with incorrect patient information.As a result, the wrong patient received prescribed treatment.Information regarding patient impact resulting from the unnecessary treatment not provided.

Manufacturer Narrative

At the conclusion of the investigation, it was determined that the cause of the incorrect final report was user error, wherein the healthcare provider swapped device registration information.This caused the patient information associated with three different patients to be associated incorrectly (i.E.Swapped).Information regarding patient impact resulting from the unnecessary treatment not provided.The device registrations have been correctly associated with the involved patients.The provided report(s) does not provide diagnosis; rather, it provides preliminary findings from which the clinician may make a diagnosis based on clinical judgement and patient clinical history.

• Brand Name: ZIO XT PATCH
• 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; 11085 knott avenue suite b; cypress CA 90630
• Manufacturer Contact: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 13745642
• MDR Text Key: 287426724
• Report Number: 3007208829-2022-00018
• Device Sequence Number: 1
• Product Code: DSH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 05/23/2022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2021
• 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): Other
• Patient Age: 32 YR
• Patient Sex: Female