BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO 100

    MDR report key: 18147888 · Received November 16, 2023

    Report

    Report Number
    3014660737-2023-69435
    Event Type
    Injury
    Date Received
    November 16, 2023
    Report Date
    November 16, 2023
    Manufacturer
    HERO HEALTH, INC.
    Product Code
    NXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE HERO DEVICE SHOULD NOT BE USED BY A RECIPIENT OF MEDICATION WHO IS INCAPABLE OF VERIFYING THE ACCURACY OF EACH DISPENSED DOSE (SUCH AS THOSE SUFFERING FROM DEMENTIA OR OTHER COGNITIVE OR PHYSICAL IMPAIRMENTS) UNLESS PILL DISPENSE ACCURACY IS BEING VERIFIED, IN EACH INSTANCE, BY QUALIFIED PERSON(S) TRUSTED BY THE MEDICATION RECIPIENT, I.E. A CAREGIVER, A HEALTHCARE AIDE, AND/OR A HEALTHCARE PROFESSIONAL. THE MEDICATION RECIPIENT (OR A TRUSTED QUALIFIED PERSON) MUST ALWAYS VERIFY THAT THE TYPES OF PILLS AND NUMBER OF PILLS DISPENSED BY THE HERO DEVICE MATCH THE PRESCRIBED OR DESIRED DOSAGE BEFORE INGESTING THE CONTENTS OF THE PILL CUP. THE HERO DEVICE SHOULD NOT BE USED TO DISPENSE MEDICINES THAT HAVE HIGH DOSAGE SENSITIVITY, THAT HAVE A NARROW THERAPEUTIC WINDOW, THAT ARE USED TO TREAT ACUTE CONDITIONS OR THAT ARE USED TO TREAT LIFE-THREATENING EVENTS. EVEN THOUGH THE HERO DEVICE IS CAPABLE OF SUCCESSFULLY AND ACCURATELY DISPENSING MOST WHOLE PILLS LOADED INTO THE DEVICE ON MOST OCCASIONS, HERO CANNOT GUARANTEE THE ACCURACY OF MEDICATION DISPENSED DURING EVERY DISPENSE CYCLE DUE TO THE POTENTIAL FOR HUMAN ERROR AND/OR MECHANICAL AND SOFTWARE LIMITATIONS OR FAILURES. THE HERO ENGINEERING TEAM INVESTIGATED THE REPORTED ISSUE AND COULD NOT CONFIRM THE CUSTOMERS CLAIMS, HOWEVER ON RARE OCCASIONS IT IS POSSIBLE THAT 2 PILLS ARE PICKED UP TOGETHER DUE TO THE HERO SMART DISPENSER DESIGN LIMITATIONS.

    Additional Manufacturer Narrative · 0

    THE HERO DEVICE SHOULD NOT BE USED BY A RECIPIENT OF MEDICATION WHO IS INCAPABLE OF VERIFYING THE ACCURACY OF EACH DISPENSED DOSE (SUCH AS THOSE SUFFERING FROM DEMENTIA OR OTHER COGNITIVE OR PHYSICAL IMPAIRMENTS) UNLESS PILL DISPENSE ACCURACY IS BEING VERIFIED, IN EACH INSTANCE, BY QUALIFIED PERSON(S) TRUSTED BY THE MEDICATION RECIPIENT, I.E. A CAREGIVER, A HEALTHCARE AIDE, AND/OR A HEALTHCARE PROFESSIONAL. THE MEDICATION RECIPIENT (OR A TRUSTED QUALIFIED PERSON) MUST ALWAYS VERIFY THAT THE TYPES OF PILLS AND NUMBER OF PILLS DISPENSED BY THE HERO DEVICE MATCH THE PRESCRIBED OR DESIRED DOSAGE BEFORE INGESTING THE CONTENTS OF THE PILL CUP. THE HERO DEVICE SHOULD NOT BE USED TO DISPENSE MEDICINES THAT HAVE HIGH DOSAGE SENSITIVITY, THAT HAVE A NARROW THERAPEUTIC WINDOW, THAT ARE USED TO TREAT ACUTE CONDITIONS OR THAT ARE USED TO TREAT LIFE-THREATENING EVENTS. EVEN THOUGH THE HERO DEVICE IS CAPABLE OF SUCCESSFULLY AND ACCURATELY DISPENSING MOST WHOLE PILLS LOADED INTO THE DEVICE ON MOST OCCASIONS, HERO CANNOT GUARANTEE THE ACCURACY OF MEDICATION DISPENSED DURING EVERY DISPENSE CYCLE DUE TO THE POTENTIAL FOR HUMAN ERROR AND/OR MECHANICAL AND SOFTWARE LIMITATIONS OR FAILURES. THE ROOT CAUSE OF THE REPORTED INCIDENT CANNOT BE CONFIRMED CONCLUSIVELY, AS THE ISSUE COULD NOT BE REPRODUCED IN THE RETURNED DEVICE. THE DEVICE PASSED ALL FUNCTIONAL TESTS.

    Description of Event or Problem · 0

    THE USER REPORTED THAT THE HERO SMART DISPENSER DOUBLE DOSED THEM ON THEIR BLOOD PRESSURE MEDICATIONS. ON (B)(6) 2023 IT WAS ADDITIONALLY REPORTED THAT DUE TO THE SYMPTOMS THEY'VE EXPERIENCED, THEY WERE ADMITTED TO THE EMERGENCY DEPARTMENT FOR FLUIDS, MONITORING, LABS. THE USER REPORTED HIGHER LOSARTAN LEVELS THAN NEEDED. THE HERO ENGINEERING TEAM INVESTIGATED THE REPORTED ISSUE AND COULD NOT CONFIRM THE CUSTOMERS CLAIMS, HOWEVER ON RARE OCCASIONS IT IS POSSIBLE THAT 2 PILLS ARE PICKED UP TOGETHER DUE TO THE HERO SMART DISPENSER DESIGN LIMITATIONS.

    Description of Event or Problem · 0

    ON (B)(6) 2023 THE USER REPORTED THAT THE HERO SMART DISPENSER DOUBLE DOSED THEM ON THEIR BLOOD PRESSURE MEDICATIONS. ON (B)(6) 2023 IT WAS ADDITIONALLY REPORTED THAT DUE TO THE SYMPTOMS THEY'VE EXPERIENCED, THEY WERE ADMITTED TO THE EMERGENCY DEPARTMENT FOR FOR FLUIDS, MONITORING, LABS. THE USER REPORTED HIGHER LOSARTAN LEVELS THAN NEEDED. THE HERO ENGINEERING TEAM INVESTIGATED THE REPORTED ISSUE AND COULD NOT CONFIRM THE CUSTOMERS CLAIMS, HOWEVER ON RARE OCCASIONS IT IS POSSIBLE THAT 2 PILLS ARE PICKED UP TOGETHER DUE TO THE HERO SMART DISPENSER DESIGN LIMITATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237662 HERO 100 DISPENSER, SOLID MEDICATION NXB HERO HEALTH, INC. H100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization LOSARTAN POTASSIUM 50MG| LOSARTAN POTASSIUM 50MG