BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOME KARDIA

    MDR report key: 11222322 · Received January 25, 2021

    Report

    Report Number
    11222322
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Date of Event
    January 8, 2021
    Report Date
    January 15, 2021
    Manufacturer
    INFOBIONIC, INC.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS AFTERNOON WE WERE MADE AWARE OF A TECHNICAL ISSUE AT INFOBIONIC (HEART RHYTHM DEVICE VENDOR), WHICH CAUSED A RESEARCH STUDY PARTICIPANT TO BE INCORRECTLY DIAGNOSED WITH ATRIAL FIBRILLATION. AT THE TIME OF DIAGNOSIS, THE PATIENT AND THEIR PHYSICIAN WERE NOTIFIED OF THE DIAGNOSIS. WHEN ONE OF THE EMPLOYEES IN THE MONITORING LAB WAS FINALIZING THE PARTICIPANT'S REPORT, THEY NOTICED THE ERROR AND NOTIFIED THE PI AND TEAM. INFOBIONIC HAS SINCE RESOLVED THE TECHNICAL ISSUE AND THIS SITUATION WILL NOT OCCUR AGAIN. THE PHYSICIAN ON THE RESEARCH STUDY NOTIFIED THE PATIENT AND THEIR PHYSICIAN OF THE SITUATION. THE PARTICIPANT DID NOT RECEIVE ANY TREATMENT AND HAD NOT SOUGHT ANY CARE RELATED TO THE FALSE DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118422 MOME KARDIA DETECTOR AND ALARM, ARRHYTHMIA DSI INFOBIONIC, INC. 01854

    Patients

    Seq Age Sex Outcome Treatment
    1