BEUDAMED
    FDA Adverse Event Death Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 8193108 · Received December 23, 2018

    Report

    Report Number
    3010606081-2018-00022
    Event Type
    Death
    Date Received
    December 23, 2018
    Date of Event
    November 30, 2018
    Report Date
    December 23, 2018
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE CUSTOMER (B)(6) WIFE CALLED TO REPORT THAT HER HUSBAND PASSED AWAY. SHE SAID THAT THEY ARE NOT SURE IF THE DEATH IS RELATED TO HIS DIABETES. THE DEATH IS NOT RELATED TO THE USE OF THE DARION METER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032341 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD. 1021-04 1805021

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death