BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO SMART GLUCOSE MONITOR

    MDR report key: 17855664 · Received September 29, 2023

    Report

    Report Number
    MW5146352
    Event Type
    Malfunction
    Date Received
    September 29, 2023
    Date of Event
    September 23, 2023
    Report Date
    September 27, 2023
    Manufacturer
    LABSTYLE INNOVATIONS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    UNABLE TO USE DEVICES AFTER UPGRADING IPHONE. RECEIVED AN EMAIL FROM DARIO TECH SUPPORT AFTER REPORTING ISSUE. EVIDENTLY, THE DARIO BLOOD GLUCOSE MONITORING SYSTEM ISN'T COMPATIBLE WITH THE IPHONE 15, OBVIOUSLY SINCE IT HAS A NEW USB-C PORT. AN ADAPTER WILL NOT WORK SINCE THE COMPANY HASN'T RECEIVED FDA APPROVAL FOR THE IPHONE 15. IN ADDITION THE DEVICE ISN'T COMPATIBLE WITH IOS 17 AND THEY HAVE NO IDEA WHEN TESTING WILL BE COMPLETED. THIS IS A PROBLEM THAT THE COMPANY SHOULD HAVE ANTICIPATED AND WARNED CONSUMERS OF THIS ISSUE BEFORE THEY WERE LEFT WITH IN INOPERABLE GLUCOSE TESTING SYSTEM. I WAS ABLE TO SECURE AN ALTERNATE SYSTEM, AND NO HARM WAS DONE. IT APPEARS THAT DARIO HAS FORGOTTEN THEY ARE SUPPLYING A MEDICAL DEVICE. COMMUNICATION WITH THE CUSTOMER BASE IS VITAL. IN THIS CASE THEY FAILED TO MEET REASONABLE EXPECTATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761068 DARIO SMART GLUCOSE MONITOR SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LABSTYLE INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other