BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIO AT

    MDR report key: 16030863 · Received December 21, 2022

    Report

    Report Number
    3007208829-2022-00061
    Event Type
    Death
    Date Received
    December 21, 2022
    Date of Event
    January 13, 2022
    Report Date
    November 30, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS FOR NEW ESTABLISHED CRITERIA FOR ADVERSE EVENT REPORTING. THE INVESTIGATION REVEALED THAT THIS WAS A USE ERROR ON BEHALF OF THE HEALTHCARE PROFESSIONALS WHO REGISTERED THE DEVICE FOR THE WRONG PATIENT. A REVIEW OF THIS COMPLAINT AND DEVICE INDICATES THE FAILURE IS NOT RELATED TO THE DEVICE. A FOLLOW-UP MDR WILL BE SUBMITTED SHOULD NEW SIGNIFICANT INFORMATION BE OBTAINED RELATIVE TO THIS EVENT.

    Description of Event or Problem · 0

    PER AN UPDATE TO THE CRITERIA FOR REPORTABLE EVENTS, THIS MDR IS BEING SUBMITTED. ON (B)(6) 2022 A PATIENT EXPIRATION WAS IDENTIFIED AS PART OF A RETROSPECTIVE REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2858081 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA DSI IRHYTHM TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Death