BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 8027846 · Received November 1, 2018

    Report

    Report Number
    3010606081-2018-00016
    Event Type
    Injury
    Date Received
    November 1, 2018
    Date of Event
    October 1, 2018
    Report Date
    November 1, 2018
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE CUSTOMER CONTACTED DARIO TO REPORT THAT SHE WENT TO THE EMERGENCY ROOM DUE TO A HIGH READING OF 572 MG/DL. AT THE EMERGENCY ROOM, HER BLOOD GLUCOSE LEVEL WAS 120 MG/DL. THE INVESTIGATION CONCLUDED THAT CUSTOMER WAS USING AN OPERATING SYSTEM ((B)(6)) THAT WAS NOT SUPPORTED WITH THE DARIO APPLICATION AT THE TIME. (B)(6) BECAME SUPPORTED ON (B)(4) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867693 DARIO BLOOD GLUCOSE MONITORING SYSTEM SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LABSTYLE INNOVATIONS LTD. 1021-04 1804211

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization