BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO GLUCOSE MONITOR

    MDR report key: 18757394 · Received February 21, 2024

    Report

    Report Number
    MW5151788
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    February 1, 2024
    Report Date
    February 17, 2024
    Manufacturer
    LABSTYLE INNOVATIONS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE OWN SEVERAL DARIO GLUCOSE DEVICES. RECENTLY TWO HAVE STOPPED WORKING, BUT A THIRD ONE CONTINUES TO WORK. WHEN I REACHED OUT TO DARIO, THEY IMPLIED IT WAS A SOFTWARE ISSUE. HOWEVER, IF IT WERE A SOFTWARE ISSUES NONE OF THE DARIO DEVICES SHOULD WORK. I EXPLAINED TO THEM THIS ISSUE, HOWEVER THEY SEEM TO HAVE NO ANSWER. I BELIEVE THAT THE TWO DARIO DEVICES I HAVE ARE EITHER DEFECTIVE OR THEY WERE DESIGNED TO ONLY WORK FOR A SPECIFIC AMOUNT OF TIME AND AS DIABETICS WE NEED TO DEPEND ON OUR DEVICES TO WORK. REFERENCE REPORT: MW5151789.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237547 DARIO GLUCOSE MONITOR SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LABSTYLE INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female