BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE APPLICATION FOR ANDROID: MEDISAFE

    MDR report key: 20452734 · Received October 11, 2024

    Report

    Report Number
    MW5161036
    Event Type
    Malfunction
    Date Received
    October 11, 2024
    Date of Event
    October 8, 2024
    Report Date
    October 8, 2024
    Manufacturer
    MEDISAFE
    Product Code
    NXQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MOBILE SOFTWARE FOR TRACKING/REMINDING FOR MEDICATIONS. I'VE REPORTED TO THEM ALL YEAR ABOUT MANY INCIDENTS WHERE IT NOT ONLY MISRECORDED INFORMATION, IT RESULTED IN THE APPLICATION ALERTING THE USER THAT THEY NEEDED TO TAKE THEIR MEDS - EVEN IF THEY ALREADY ENTERED THAT INTO THE APP. I FEAR ANYBODY LESS COGNITIVELY PRESENT WOULD TAKE MULTIPLE DOSES, WHICH IS OBVIOUSLY VERY SERIOUS. I HAVE EMAIL EXCHANGES SHOWING THEY UNDERSTOOD THE PROBLEM, BUT APPARENTLY HAVEN'T CORRECTED IT. THEY KEEP ASKING ME FOR MORE EXAMPLES, AND I'VE PROVIDED *MANY* - INCLUDING SHOWING THERE ARE MANY USE CASE PATHS THAT CAUSE THE PROBLEM, YET THE APP HAS NOT BEEN CORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345366 MOBILE APPLICATION FOR ANDROID: MEDISAFE REMINDER, MEDICATION NXQ MEDISAFE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male