BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 8027881 · Received November 1, 2018

    Report

    Report Number
    3010606081-2018-00017
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE CUSTOMER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE READINGS (482-512 MG/DL). AS A RESULT, HE WENT TO THE HOSPITAL. AT THE HOSPITAL HIS BLOOD GLUCOSE WAS 330 MG/DL. DARIO ATTEMPTED TO FOLLOW UP WITH THE USER ON MULTIPLE OCCASIONS WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869221 DARIO BLOOD GLUCOSE MONITORING SYSTEM SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LABSTYLE INNOVATIONS LTD. 1021-02 0804171

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization