BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIO AT

    MDR report key: 16241126 · Received January 25, 2023

    Report

    Report Number
    3007208829-2023-00008
    Event Type
    Injury
    Date Received
    January 25, 2023
    Date of Event
    February 8, 2022
    Report Date
    December 29, 2022
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    DSI
    PMA / PMN Number
    K163512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 11 FEB 2022, A CLINICAL OPERATIONS MANAGER REPORTED THERE WAS A DELAYED MDN COMPLICATION DURING THE WEAR PERIOD AND REQUESTED VERIFICATION FOR ANY MALFUNCTION IN TRANSMITTING ON (B)(6) 2022. THERE WAS AN EVENT THAT OCCURRED (B)(6) 2022 8:47 AM EST REQUIRING MDN WITH TRANSMISSION ID (B)(6), BUT THE TRANSMISSION WAS DELAYED AND RECEIVED APPROXIMATELY 10 HOURS LATER FOR VT. ANALYSIS OF THE GATEWAY DEBUG LOG REVEALED THAT THE GATEWAY EXPERIENCED REGISTRATION TIMEOUT LOGS DUE TO POOR CELLULAR CONNECTIONS. THUS, GATEWAY CELL CONNECTIONS WERE DELAYED UNTIL GOOD CELLULAR RECEPTION WAS MADE AVAILABLE; ATTRIBUTING TO THE DELAYED EPISODE TRANSMISSION. THE GATEWAY WAS ABLE TO RECOVER AND CONTINUE NORMAL OPERATION CLEARING ALL BACKED UP RPEAKS THROUGH THE SERVER SUBSEQUENTLY WITH LAST RPEAK ACKEDID= 3282 (3282 IS THE LAST RPEAK POSSIBLE). NO OTHER PERFORMANCE OR FUNCTIONAL ISSUES WERE FOUND AROUND THE TIME OF THE ALLEGED EVENT NOR THE SUBSEQUENT WEAR PERIOD. THERE IS NO INDICATION THERE WAS ANY DEVICE MALFUNCTION (21 CFR 803) OR ECG MONITORING (42 CFR 410) DEFICIENCY THAT CAUSED OR CONTRIBUTED TO THIS HOSPITALIZATION. LOSS OF CONNECTIVITY IS A KNOWN INHERENT RISK OF THE DEVICE. ZIO AT LABELING CONTAINS THE FOLLOWING WARNING: DO NOT USE THE ZIO AT ON PATIENTS RESIDING IN AREAS WITH LIMITED TO NO CELLULAR RECEPTION.

    Description of Event or Problem · 0

    THIS MDR IS BEING FILED AS THE RESULT OF AN UPDATE TO OUR ADVERSE EVENT REPORTING PROCEDURE. THE EVENT OCCURRED ON (B)(6) 2022, BUT DUE TO THE NEW CRITERIA, THE AWARENESS DATE IS 29 DEC 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175935 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA DSI IRHYTHM TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Hospitalization