BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIO AT

    MDR report key: 20015489 · Received August 21, 2024

    Report

    Report Number
    3007208829-2024-00434
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    July 20, 2024
    Report Date
    June 20, 2025
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    QYX
    UDI-DI
    00869770000210
    PMA / PMN Number
    K163512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED IN RESPONSE TO FDA CESUBHELPDESK-36883 TICKET 397826 REGARDING A DISCREPANCY WITH THE SUBMISSION DATE FOR MDR 3007208829-2024-00434. THE REPORT WAS SUBMITTED ON TIME ON AUGUST 19, 2024, AT 5:01:42 PM, AND A TIMESTAMPED WEBTRADER RECEIPT (ACK 1) WAS RECEIVED, CONFIRMING DELIVERY. HOWEVER, IT WAS NOTED THAT ACKS 2 AND 3 WERE NOT RECEIVED. ESG SENT A NOTIFICATION THAT THE ADDITIONAL ACKNOWLEDGMENTS WERE DELAYED AND WOULD BE PROVIDED WITHIN 1 TO 2 DAYS. CONSEQUENTLY, THE REPORT'S DELIVERY DATE IS RECORDED AS AUGUST 21, 2024, AT 4:19:29 PM EDT, WHICH GIVES THE IMPRESSION THAT THE MDR WAS SUBMITTED LATE.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THIS COMPLAINT REVEALED THAT ON DAY 1, AN INTERNAL SERVICE TICKET WAS GENERATED, WHICH IDENTIFIED THAT THE DEVICE WAS NOT TRANSMITTING. ON DAY 2, IRHYTHM ATTEMPTED TO CONTACT THE PATIENT, LEAVING A VOICEMAIL AND EMAILING THE ACCOUNT. THE ACCOUNT RESPONDED TO IRHYTHM¿S INQUIRY AND INFORMED US THAT THE PATIENT HAD BEEN HOSPITALIZED AND DID NOT HAVE THE GATEWAY. ADDITIONALLY, THE ER PHYSICIAN CONTACTED THE ACCOUNT FOR A DEVICE DATA REQUEST (DDR) FOR THE TIMEFRAME DURING WHICH THE PATIENT EXPERIENCED SYMPTOMS. THE ZIO AT DEVICE WAS RETURNED TO IRHYTHM, AND THE CLINICAL DATA WAS UPLOADED FOR PROCESSING. A REVIEW OF THE CLINICAL DATA FOUND THAT THE PATIENT WORE THE ZIO AT DEVICE FOR THE 14-DAY PRESCRIBED WEAR PERIOD. IT WAS DISCOVERED THAT THE TWO ACTIONABLE ARRHYTHMIAS DID NOT TRANSMIT DUE TO THE GATEWAY NOT BEING ACTIVATED AT THE TIME OF WEAR. IRHYTHM BECAME AWARE OF THE ARRHYTHMIAS WHILE PREPARING THE FINAL REPORT AND NOTIFIED THE HCP ON DAY 26. DURING NOTIFICATION, IRHYTHM LEARNED THAT THE HCP WAS ALREADY AWARE OF THE PATIENT'S ARRHYTHMIA AND THAT AN ABLATION PROCEDURE WAS SCHEDULED FOR A LATER DATE. THE CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO USER ERROR. THE ZIO AT DEVICE MANUAL PROVIDES WARNINGS TO TRANSPORT THE GATEWAY WITH THE PATCH. THE ZIO AT PACKAGE CONTAINS INSTRUCTIONS ON HOW TO APPLY THE PATCH AND ACTIVATE THE PATCH AND GATEWAY, AS IT REFERS THE USER TO THE APPLICATION INSTRUCTION MANUAL. CLINICIANS, ADVISE YOUR PATIENTS: IF YOU FEEL THE NEED FOR IMMEDIATE MEDICAL ATTENTION AT ANY TIME, CALL 911. THE ZIO AT DEVICE WILL NOT PROVIDE ANY MEDICAL ASSISTANCE, AND YOU CANNOT CONTACT THE MEDICAL PERSONNEL FOR YOU. PLEASE TAKE YOUR GATEWAY TO THE EMERGENCY ROOM WITH YOU. APPLICATION INSTRUCTIONS (INSTRUCTIONS ARE ON PAGE 14 IN SECTION 4.) OPEN THE GATEWAY AND PRESS THE STAR BUTTON UNTIL YOU FEEL A CLICK. THE LIGHTS WILL FLASH ORANGE THEN GREEN. WHEN THE FLASHING LIGHT STOPS, THE GATEWAY IS CONNECTED TO YOUR ZIO PATCH.

    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 TWO ARRHYTHMIAS THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WERE NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONCLUDED THAT THE GATEWAY WAS NOT ACTIVATED DURING THE WEAR PERIOD. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEART PALPITATIONS AND PASSED OUT. THE PATIENT WAS THEN TAKEN TO THE EMERGENCY ROOM FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2179027 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA QYX IRHYTHM TECHNOLOGIES, INC 00869770000210

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Hospitalization