BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIO XT

    MDR report key: 19923594 · Received August 6, 2024

    Report

    Report Number
    3007208829-2024-00418
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    June 5, 2024
    Report Date
    June 23, 2025
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    DSH
    UDI-DI
    00869770000203
    PMA / PMN Number
    K121319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    SINCE NO SERIAL NUMBER WAS PROVIDED FOR THE SUBJECT DEVICE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IRHYTHM WAS UNABLE TO FOLLOW UP WITH THE PATIENT AS NO CONTACT INFORMATION WAS PROVIDED; THEREFORE, NO ADDITIONAL INFORMATION IS AVAILABLE. 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.

    Description of Event or Problem · 0

    ON JULY 17, 2024, IRHYTHM RECEIVED A MEDWATCH REPORT (MW5156490) INDICATING THAT A PATIENT WAS PRESCRIBED A ZIO DEVICE TO MONITOR AN ABNORMAL ARRHYTHMIA. THE REPORT STATES THAT THE PATIENT EXPERIENCED AN INFLAMED SKIN IRRITATION AND THAT THE DEVICE FAILED, AS IT DETACHED THREE TIMES FROM THE PATIENT¿S CHEST. ACCORDING TO THE REPORT, THIS CAUSED THE PATIENT'S RESULTS TO BE INCORRECT AND WAY OUT OF RANGE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702745 ZIO XT RECORDER, MAGNETIC TAPE, MEDICAL DSH IRHYTHM TECHNOLOGIES, INC 00869770000203

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female