BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIEGRID PILL BOX

    MDR report key: 10109183 · Received June 1, 2020

    Report

    Report Number
    MW5094794
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Report Date
    May 28, 2020
    Manufacturer
    UNK
    Product Code
    NXQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USING A SMART PILL BOX WITH ALARMS THAT TELL ME HOW MANY AND WHEN TO TAKE MEDICATION IT TOLD ME TO TAKE A QUANTITY OF 5 FOR 2 DIFFERENT MEDICATIONS THAT COULD HAVE LED TO SERIOUS HEALTH EFFECTS UP TO AND INCLUDING HEART ATTACK FOR THE DOSAGE IT TOLD ME TO TAKE. I REALIZED THE ERROR AND NOTIFIED THE MANUFACTURER AND THEY SAID THERE WAS A BUG IN THE SYSTEM AND THEY WERE WORKING ON THE PROBLEM. HOWEVER THEY DID NOT SEND COMMUNICATION BLOUNT TO USERS STATING THIS COULD BE ERRORS. THIS IS FOR ELLIEGRID SMART PILLBOX. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570978 ELLIEGRID PILL BOX REMINDER, MEDICATION NXQ UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR