BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIO AT

    MDR report key: 18440260 · Received January 3, 2024

    Report

    Report Number
    3007208829-2024-00002
    Event Type
    Death
    Date Received
    January 3, 2024
    Date of Event
    October 1, 2023
    Report Date
    June 23, 2025
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    QYX
    UDI-DI
    00869770000210
    PMA / PMN Number
    K163512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THIS COMPLAINT DISCOVERED THAT THE PATIENT WAS PRESCRIBED A ZIO AT DEVICE. ON DAY 11 IRHYTHM CALLED THE PATIENT TO FOLLOW UP ON THE ¿NO CONNECTION¿ STATUS, AND IRHYTHM WAS INFORMED THAT THE PATIENT HAD EXPIRED AT HOME ALONE ON DAY 9. NO FURTHER INFORMATION REGARDING THE PATIENT¿S CAUSE OF DEATH WAS PROVIDED. THE ZIO AT WAS NOT RETURNED TO IRHYTHM FOR EVALUATION. AVAILABLE DEVICE DATA INDICATES THAT THE PATCH WAS REMOVED FROM THE PATIENT ON DAY 9. THERE WERE ACTIONABLE ARRHYTHMIAS IDENTIFIED THAT DID MEET AUTO-DETECTION CRITERIA DURING THE PATIENT¿S WEAR TIME AND NOTIFICATION TO THE ACCOUNT WAS PERFORMED PROMPTLY. THE AT PATCH WAS NOT RETURNED, SO THE END-OF-LIFE EVENT CANNOT BE REVIEWED. HOWEVER, THE GATEWAY DEBUG LOG REVIEW CONFIRMED NO CELLULAR CONNECTIVITY ISSUES OCCURRED DURING THE PATIENT¿S WEAR TIME. THE INVESTIGATION DID NOT FIND EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH, AS IT FUNCTIONED AS INTENDED. THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. 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 SUBMISSION MATERIALS 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
    588028 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA QYX IRHYTHM TECHNOLOGIES, INC 00869770000210

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Death