BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIO AT

    MDR report key: 19639677 · Received June 28, 2024

    Report

    Report Number
    3007208829-2024-00361
    Event Type
    Death
    Date Received
    June 28, 2024
    Date of Event
    May 29, 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 Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT REVEALED THAT ON DAY 5, IRHYTHM ATTEMPTED TO FOLLOW UP ON THE ¿LEADS OFF¿ STATUS OF THE AT PATCH AND WAS INFORMED BY THE PATIENT'S FAMILY THAT THE PATIENT HAD EXPIRED THE DAY PRIOR. AS A RESULT, IRHYTHM CONTACTED THE ACCOUNT TO OBTAIN ADDITIONAL INFORMATION, BUT THE ACCOUNT DECLINED TO PROVIDE FURTHER DETAILS. THE PATIENT¿S CAUSE OF DEATH REMAINS UNKNOWN. THE ZIO AT DEVICE WAS RETURNED TO IRHYTHM, AND THE CLINICAL DATA WAS DOWNLOADED. ANALYSIS OF THE DATA FOUND THAT THE ALGORITHM DID NOT DETECT TWO ACTIONABLE ARRHYTHMIAS AND PARTIALLY TRANSMITTED A THIRD ARRHYTHMIA DURING THE APPROXIMATE 45-MINUTE END-OF-LIFE EPISODE. ALSO, A MISCLASSIFIED ARRHYTHMIA WAS FOUND BUT WAS DETERMINED TO HAVE BEEN CAUSED BY AN ERROR IN THE INTERPRETATION OF THE CERTIFIED CARDIOGRAPHIC TECHNICIAN, NOT THE DEVICE ALGORITHM. IRHYTHM BECAME AWARE OF THE ARRHYTHMIAS WHILE PREPARING THE FINAL REPORT AND NOTIFIED THE HCP ON DAY 11. IT IS UNKNOWN IF RESUSCITATION WOULD HAVE CHANGED THE OUTCOME FOR THIS PATIENT. DUE TO THE PATIENT¿S AGE AND OBSERVED ARRHYTHMIA THAT MIMICS A NATURAL END-OF-LIFE PROGRESSION IN THE MIDDLE OF THE NIGHT, IT IS UNLIKELY THAT THE DEVICE CAUSED OR CONTRIBUTED TO THIS PATIENT¿S END-OF-LIFE. THIS EVENT IS BEING REPORTED PER 21CFR 803 AS AN ADVERSE EVENT. 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 FORMFDA 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 EXPIRED DURING THEIR PRESCRIBED ZIO AT WEAR PERIOD. IRHYTHM ATTEMPTED TO GATHER MORE INFORMATION ABOUT THE CAUSE OF DEATH FROM THE ACCOUNT, BUT NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2192671 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA QYX IRHYTHM TECHNOLOGIES, INC 00869770000210

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Male Death