BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIO AT

    MDR report key: 19719187 · Received July 11, 2024

    Report

    Report Number
    3007208829-2024-00393
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 9, 2024
    Report Date
    June 20, 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 DEVICE WAS RETURNED TO IRHYTHM, AND THE CLINICAL DATA WAS DOWNLOADED. A REVIEW OF THE CLINICAL DATA REVEALED THAT THE DEVICE WAS WORN FOR THE 14-DAY PRESCRIBED WEAR PERIOD. ON DAY 13, THE DEVICE REACHED THE MAXIMUM TRANSMISSION LIMIT AND STOPPED TRANSMITTING ASYMPTOMATIC EVENTS. THE HCP ACCOUNT WAS NOTIFIED ON DAY 10 THAT THE DEVICE WAS APPROACHING THE MAXIMUM TRANSMISSION LIMIT, AND A REPLACEMENT DEVICE WAS SHIPPED. IRHYTHM BECAME AWARE OF THE ARRHYTHMIA WHILE PREPARING THE FINAL REPORT AND NOTIFIED THE HCP ON DAY 17. AS DESCRIBED IN THE PRODUCT LABELING, THE ZIO AT DEVICE HAS A MAXIMUM THRESHOLD OF TRANSMITTING 100 PATIENT TRIGGERS AND 500 ASYMPTOMATIC TRANSMISSIONS DURING WEAR. WHEN A PATIENT IS APPROACHING THE LIMIT FOR EITHER TRANSMISSION TYPE, IRHYTHM REACHES OUT TO THE ACCOUNT TO DETERMINE WHETHER TO SEND ANOTHER AT DEVICE TO THE PATIENT. PATIENT-TRIGGERED SYMPTOMATIC TRANSMISSIONS ARE STILL ABLE TO BE TRANSMITTED BEYOND THIS LIMIT BY PRESSING THE LARGE CENTRAL BUTTON LOCATED ON THE OUTER DEVICE HOUSING. THE TRANSMISSION LIMIT COUNTER IS REFLECTED ON DAILY REPORTS AVAILABLE TO THE HCP AND IN THE ZIO SUITE PORTAL. 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 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 CONFIRMED THE ZIO AT REACHED THE MAXIMUM TRANSMISSION LIMIT. THE HCP ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE MAXIMUM TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS SHIPPED. ADDITIONAL FOLLOW-UP WAS PERFORMED, AND THE HEALTHCARE PROVIDER (HCP) WAS IMMEDIATELY NOTIFIED OF THE PATIENT'S ARRHYTHMIA, BUT IT WAS UNCLEAR WHETHER THE PATIENT WOULD RECEIVE TREATMENT AS THE ACCOUNT DECLINED TO PROVIDE ANY ADDITIONAL DETAILS. 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
    2380631 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA QYX IRHYTHM TECHNOLOGIES, INC 00869770000210

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male