BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIO AT

    MDR report key: 19778889 · Received July 18, 2024

    Report

    Report Number
    3007208829-2024-00409
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    June 12, 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 Location
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ZIO AT DEVICE WAS RETURNED, AND THE CLINICAL DATA WAS DOWNLOADED. A REVIEW OF THE CLINICAL DATA FOUND THAT THE PATIENT WORE THE AT DEVICE FOR 9 DAYS OF THE 14-DAY PRESCRIBED WEAR PERIOD. IRHYTHM BECAME AWARE OF THE MISCLASSIFIED ARRHYTHMIA WHILE PREPARING THE FINAL REPORT AND NOTIFIED THE HCP ON DAY 21. THE DIAGNOSTIC DATA INDICATES THAT NO FUNCTIONAL ISSUES WERE OBSERVED FOR THE DEVICE AROUND THE TIME OF THE SPECIFIED EPISODE. ANALYSIS OF DEVICE LOGS FOUND THAT THE DEVICE PERFORMED AS INTENDED WITH NO PERFORMANCE OR FUNCTIONAL ISSUES NOTED. THE INVESTIGATION REVEALED THE MISCLASSIFIED ARRHYTHMIA WAS NOT CAUSED BY THE ALGORITHM, BUT RATHER BY AN ERROR IN INTERPRETATION BY THE CERTIFIED CARDIOGRAPHIC TECHNICIAN. THIS EVENT IS BEING REPORTED PER 21CFR803 AS A SERIOUS INJURY. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY RHYTHM 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. THE AT CLINICAL REFERENCE MANUAL STATES IN THE ¿INDICATIONS FOR USE¿ SECTION THAT ¿THE REPORTS ARE PROVIDED FOR REVIEW BY THE INTENDED USER TO RENDER A DIAGNOSIS BASED ON CLINICAL JUDGMENT AND EXPERIENCE.¿

    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 COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THE HEALTHCARE PROVIDER (HCP) WAS IMMEDIATELY NOTIFIED, AND IRHYTHM LEARNED THAT THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM (ER) AND RECEIVED A PACEMAKER DUE TO THE INITIAL INTERPRETATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555882 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA QYX IRHYTHM TECHNOLOGIES, INC 00869770000210

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other