BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIO AT

    MDR report key: 17819903 · Received September 26, 2023

    Report

    Report Number
    3007208829-2023-00102
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    April 23, 2023
    Report Date
    September 25, 2023
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    DSI
    PMA / PMN Number
    K163512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE HCP ACCOUNT WAS NOTIFIED ON DAY 7 THAT THE DEVICE HAD MET THE ASYMPTOMATIC TRANSMISSION LIMIT, AND A REPLACEMENT DEVICE ZIO AT PATCH AND GATEWAY WAS SHIPPED. IRHYTHM BECAME AWARE OF THE ARRHYTHMIA WHILE PREPARING FINAL REPORT AND NOTIFIED THE HCP ON DAY 28. AS DESCRIBED IN 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 CLINICIAN TO INFORM THE CLINICIAN THAT A REPLACEMENT ZIO AT PATCH AND GATEWAY WILL BE SENT, UNLESS A CLINICIAN REPRESENTATIVE DETERMINES A REPLACEMENT IS NOT NEEDED. IN KEEPING WITH FDA¿S POSITION ON REPORTING EXPECTATIONS AS COMMUNICATED TO THE COMPANY IN MAY 2023, IRHYTHM ALIGNED TO A REPORTING APPROACH FOR MDNS THAT WERE NOT COMMUNICATED DURING THE WEAR PERIOD DUE TO A MAXIMUM TRANSMISSION LIMIT BEING REACH, AND AGREED TO TREAT THESE INSTANCES AS MALFUNCTION MDRS FOR REPORTING PURPOSES. MALFUNCTION. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY IRHYTHM THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED. CERTAIN TERMS INCLUDED IN FORM FDA 3500A AND RELATED MDR.

    Description of Event or Problem · 0

    NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED. THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET THE CRITERIA FOR MEDICAL DOCTOR NOTIFICATION (MDN) (ARRHYTHMIAS OF CLINICAL INTEREST DURING THE PRODUCT WEAR PERIOD) FOR THE HCP LOCATION, BUT THAT WAS NOT CONVEYED TO THE HCP LOCATION DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THAT THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT FOR THE ZIO AT DEVICE, PROMPTING A CONTACT TO THE HCP ACCOUNT. UNDER THE PROCESS IN PLACE AT THE TIME OF THIS EVENT, AN APPROACHING TRANSMISSION LIMIT AND A TRANSMISSION LIMIT BEING REACHED WOULD PROMPT CONTACT TO THE HCP ACCOUNT, IN TANDEM WITH PRECAUTIONS DISCUSSED IN THE LABELING AND ¿TRIGGER OFF¿ ICONS PRESENTED TO HCP ACCOUNTS ON THE ZIO AT DAILY REPORTS WHEN A TRANSMISSION LIMIT HAD BEEN REACHED. THE HCP WAS NOTIFIED THAT THE DEVICE HAD MET THE ASYMPTOMATIC TRANSMISSION LIMIT, PRIOR TO THE NOTED ARRHYTHMIA, AND A REPLACEMENT DEVICE WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832143 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA DSI IRHYTHM TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male