BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 8338712 · Received February 14, 2019

    Report

    Report Number
    3010606081-2019-00004
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    January 17, 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 CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE READINGS. THE USER REPORTED HE CONSULTED WITH HIS DOCTOR IN ORDER TO CHECK THE READINGS. AT THE DOCTOR, DARIO METER READINGS WERE INCONSISTENT WITH THE LAB RESULTS. THE USER REPORTED HE WAS USING ALCOHOL SWABS BEFORE TAKING MEASUREMENTS. IT IS INSTRUCTED IN DARIO USER GUIDE UNDER 'TESTING INFORMATION AND GUIDELINES': "ALCOHOL CAN AFFECT TEST RESULTS". AT THE MORNING OF (B)(6) 2019, PRIOR TO THE CALL TO DARIO, THE USER DID NOT USE ALCOHOL SWABS AND DARIO BLOOD GLUCOSE READING WAS IN RANGE. AT THE TIME OF THE CASE REPORT, THE USER OPENED A NEW STRIP CARTRIDGE AND THE READINGS WERE IN ORDER. IN ADDITION, THE USER WAS SENT CONTROL SOLUTION. ON (B)(6) 2019, THE USER TESTED WITH THE CONTROL SOLUTION - READINGS WERE IN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132659 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD. 1021-02 1606211

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization