BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIO AT

    MDR report key: 18419674 · Received December 29, 2023

    Report

    Report Number
    3007208829-2023-00219
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    November 26, 2023
    Report Date
    June 23, 2025
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    QYX
    UDI-DI
    00869770000210
    PMA / PMN Number
    K163512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AT DEVICE WAS RETURNED TO IRHYTHM, AND THE CLINICAL DATA WAS DOWNLOADED. A REVIEW OF THE CLINICAL DATA FOUND THAT THE PATIENT WORE THE AT DEVICE FOR 6 DAYS OF THE 14-DAY PRESCRIBED WEAR PERIOD. IRHYTHM BECAME AWARE OF THE ARRHYTHMIA WHILE PREPARING FINAL REPORT AND NOTIFIED THE HCP ON DAY 19. THE INVESTIGATION REVEALED A POTENTIAL ALGORITHM SENSITIVITY ISSUE WITH THE DEVICE, AS THERE WERE NO ERRORS OR ISSUES OBSERVED AROUND THE TIME THE MISSED EPISODE OCCURRED. THIS EVENT IS BEING REPORTED PER 21CFR 803 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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED IN RESPONSE TO THE FDA'S ADDITIONAL INFORMATION REQUEST RECEIVED ON JULY 09, 2024, TO PROVIDE THE UDI NUMBER FOR THE ZEUS SYSTEM ASSOCIATED WITH PRODUCT CODE DQK. A REVIEW OF THE COMPLAINT WAS PERFORMED, AND IT WAS DETERMINED THAT A SUPPLEMENTAL REPORT IS REQUIRED TO CORRECT THE SUSPECT MEDICAL DEVICE FROM ZEUS TO ZIO AT. BASED ON NEW REPORTING CRITERIA IMPLEMENTED AT THAT TIME. PLEASE SEE UPDATES TO SECTIONS (D1, D2, D4, D5, AND G4). PLEASE REFERENCE MFR. REPORT NUMBERS: 3007208829-2023-00215; 3007208829-2023-00217; 3007208829-2023-00218; 3007208829-2023-00219; 3007208829-2023-00221; 3007208829-2023-00222; 3007208829-2023-00223; 3007208829-2023-00225 RELATED TO THIS REQUEST.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED IN RESPONSE TO THE FDA NOTIFICATION RECEIVED ON SEPTEMBER 26, 2024, CONCERNING MISSING UDI NUMBERS IN MDR SUBMISSIONS FROM OCTOBER 2023 THROUGH DECEMBER 2024. IN RESPONSE TO THIS ISSUE, IRHYTHM CONDUCTED AN INVESTIGATION AND IDENTIFIED A SYSTEM PROCESSING ERROR, WHICH HAS NOW BEEN RESOLVED. PLEASE SEE THE UPDATE IN SECTION D4.

    Description of Event or Problem · 0

    THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED A POTENTIAL ALGORITHM SENSITIVITY ISSUE WITH THE DEVICE. THE HEALTHCARE PROVIDER (HCP) WAS IMMEDIATELY NOTIFIED, AND IRHYTHM LEARNED THAT THE HCP WAS ALREADY AWARE OF THE PATIENT'S ARRHYTHMIA. THERE WERE NO DELAYS IN TREATMENT, AND NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245522 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA QYX IRHYTHM TECHNOLOGIES, INC 00869770000210
    834475 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA QYX IRHYTHM TECHNOLOGIES, INC 00869770000210

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Congenital Anomaly ZIO AT/SN: (B)(6)