BEUDAMED
    FDA Adverse Event Death Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 8389338 · Received March 5, 2019

    Report

    Report Number
    3010606081-2019-00006
    Event Type
    Death
    Date Received
    March 5, 2019
    Date of Event
    February 6, 2019
    Report Date
    March 5, 2019
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE USER HUSBAND CONTACTED DARIO TO REPORT THE USER PASSED AWAY THE PREVIOUS DAY. THE HUSBAND REPORTED THE USER WAS VERY ILL AND HAD LOTS OF COMPLICATION, THEY DO NOT KNOW IF THE DEATH WAS RELATED TO DIABETES. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182268 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD. 1021-04

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death