BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARDIAMOBILE

    MDR report key: 23645310 · Received November 25, 2025

    Report

    Report Number
    3009715978-2025-00001
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    September 10, 2025
    Report Date
    November 25, 2025
    Manufacturer
    ALIVECOR, INC.
    Product Code
    DXH
    PMA / PMN Number
    K191406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE ECG DATA CONFIRMED THE DEVICE CORRECTLY CLASSIFIED THE CUSTOMER'S RHYTHM AS NORMAL SINUS RHYTHM. THE DEVICE FUNCTIONED AS INTENDED AND MET ALL SPECIFICATIONS AND IS NOT INTENDED TO DETECT MYOCARDIAL INFARCTION. THE ADVERSE EVENT IS ATTRIBUTED TO THE CUSTOMER'S FAILURE TO FOLLOW WARNINGS STATING THE DEVICE DOESN'T DETECT HEART ATTACK AND TO SEEK IMMEDIATE MEDICAL ATTENTION IF YOU BELIEVE YOU ARE HAVING A MEDICAL EMERGENCY.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE CUSTOMER WAS FEELING CHEST PAINS AND TOOK AN ECG USING HIS KARDIAMOBILE DEVICE. KARDIA'S DETERMINATION WAS NORMAL SINUS RHYTHM, AND THE CUSTOMER DECIDED NOT TO SEEK MEDICAL CARE FOR HIS SYPMTOMS. TWO DAYS LATER, HE EXPERIENCED MORE CHEST PAINS, AND WENT TO THE ER. HE WAS HAVING A HEART ATTACK. FOLLOWING THE HEART ATTACK, THE CUSTOMER EXPERIENCED A STROKE. (REPORTED IN TICKET #(B)(6)). (B)(6) MD (MEDICAL DIRECTOR, CARDIOVASCULAR SERVICES FOR (B)(6)) ASSESSED THE CUSTOMER'S KARDIA ECG FROM (B)(6) 2025, AND DETERMINED THAT KARDIA'S RESULT OF NORMAL SINUS RHYTHM WAS CORRECT. AFTER EVERY ECG TAKEN, THE KARDIA APP DISPLAYS A WARNING STATING, "KARDIA DOES NOT CHECK FOR HEART ATTACK. IF YOU BELIEVE YOU ARE HAVING A MEDICAL EMERGENCY, CALL EMERGENCY SERVICES. DO NOT CHANGE YOUR MEDICATION WITHOUT TALKING TO YOUR DOCTOR." THE CUSTOMER IGNORED THE WARNING AND DELAYED SEEKING CARE. IT IS POSSIBLE THAT HAD THE CUSTOMER NOT DELAYED SEEKING TREATMENT, HE MAY HAVE HAD A BETTER OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2562758 KARDIAMOBILE KARDIAMOBILE 1-LEAD EKG DXH ALIVECOR, INC. AC009 ACR2300006CS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Life Threatening