BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIO AT

    MDR report key: 19493949 · Received June 8, 2024

    Report

    Report Number
    3007208829-2024-00315
    Event Type
    Death
    Date Received
    June 8, 2024
    Date of Event
    April 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 Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THIS COMPLAINT DISCOVERED THAT THE PATIENT WAS PRESCRIBED A ZIO AT DEVICE. AVAILABLE DATA INDICATES THAT THE PATCH WAS ACTIVATED AND REGISTERED ON (B)(6) 2024. HOWEVER, THE GATEWAY DOES NOT APPEAR TO HAVE BEEN ACTIVATED, AS NO TRANSMISSIONS WERE RECEIVED DURING THE PATIENT¿S WEAR PERIOD. ON DAY 2, IRHYTHM CALLED THE PATIENT TO FOLLOW UP ON THE ¿NO CONNECTION¿ STATUS AND LEFT A VOICEMAIL. ON THE SAME DAY, IRHYTHM SENT A NOTIFICATION VIA EMAIL TO THE ACCOUNT INFORMING THEM THAT THE PATIENT RECEIVED THEIR DEVICE, BUT IT HAD NOT BEEN ACTIVATED. NO RESPONSE WAS RECEIVED FROM THE PATIENT OR THE ACCOUNT. ON DAY 48, THE PATIENT'S FAMILY CONTACTED IRHYTHM AND REPORTED THAT THE PATIENT HAD EXPIRED. AS A RESULT, IRHYTHM FOLLOWED UP WITH THE ACCOUNT FOR ADDITIONAL INFORMATION AND WAS INFORMED THAT THE ACCOUNT WAS NOT AWARE THAT THE PATIENT HAD EXPIRED. THE ACCOUNT STATED THEY WOULD INFORM THE MEDICAL DOCTOR. SINCE NO ADDITIONAL DETAILS WERE PROVIDED, THE PATIENT¿S CAUSE OF DEATH IS UNKNOWN. THE ZIO AT PATCH WAS NOT RETURNED TO IRHYTHM; HOWEVER, THE GATEWAY DEVICE WAS RECEIVED. THE REASON FOR THE ARRHYTHMIA NOT TRANSMITTING COULD NOT BE DETERMINED AS THE GATEWAY DEBUG LOG WAS NOT AVAILABLE. BASED ON THE AVAILABLE DATA, THERE WAS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. 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 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
    2318928 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA QYX IRHYTHM TECHNOLOGIES, INC 00869770000210

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Death