MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO XT PATCH; ZIO PATCH

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

Follow up with the physician's office confirmed that there was no delay in treatment as a result of the misclassified rhythm.Patient was admitted to the hospital for treatment and subsequently discharged.

Event Description

During retrospective review, it was found that the report incorrectly classified a rhythm and was sent to the physician.Report was amended and reported.

• Brand Name: ZIO XT PATCH
• Type of Device: ZIO PATCH
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC; 650 townsend; suite 500; san francisco CA 94103
• Manufacturer (Section G): IRHYTHM TECH, INC; 11085 knott avenue; suite b; cypress CA 90630
• Manufacturer Contact: rich laguna ; 650 townsend; suite 500; san francisco, CA 94103 ; 4156325749
• MDR Report Key: 8474918
• MDR Text Key: 145941354
• Report Number: 3007208829-2019-00020
• Device Sequence Number: 1
• Product Code: DSH
• UDI-Device Identifier: 00869770000203
• UDI-Public: 00869770000203
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/08/2019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Date Manufacturer Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2019
• 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: 72 YR