BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIO AT

    MDR report key: 19660713 · Received July 2, 2024

    Report

    Report Number
    3007208829-2024-00364
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 4, 2024
    Report Date
    June 20, 2025
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    QYX
    UDI-DI
    00869770000210
    PMA / PMN Number
    K163512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO IRHYTHM, AND THE CLINICAL DATA WAS DOWNLOADED. A REVIEW OF THE CLINICAL DATA REVEALED THE DEVICE WAS WORN FOR 13 DAYS FOR THE 14-DAY PRESCRIBED WEAR PERIOD. THE DEVICE REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT AND STOPPED TRANSMITTING ASYMPTOMATIC EVENTS ON DAY 9. THE HCP ACCOUNT WAS ALSO NOTIFIED ON DAY 4 THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT, AND A REPLACEMENT DEVICE WAS SHIPPED. IRHYTHM BECAME AWARE OF THE ARRHYTHMIA WHILE PREPARING THE FINAL REPORT AND NOTIFIED THE HCP ON DAY 20. 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 ACCOUNT TO DETERMINE WHETHER TO SEND ANOTHER AT DEVICE TO THE PATIENT. PATIENT-TRIGGERED SYMPTOMATIC TRANSMISSIONS ARE STILL ABLE TO BE TRANSMITTED BEYOND THIS LIMIT BY PRESSING THE LARGE CENTRAL BUTTON LOCATED ON THE OUTER DEVICE HOUSING. THIS EVENT IS BEING REPORTED PER 21CFR 803 AS A PRODUCT PROBLEM /MALFUNCTION. 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 FORM FDA 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 EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT. THE HCP ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS SHIPPED. ADDITIONAL FOLLOW-UP WAS PERFORMED WITH THE ACCOUNT, AND IRHYTHM LEARNED THAT THE PATIENT HAD BEEN HOSPITALIZED AND WAS TREATED FOR THE ARRHYTHMIA. THERE WERE NO DELAYS IN TREATMENT, AND NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760125 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA QYX IRHYTHM TECHNOLOGIES, INC 00869770000210

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male