BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 8136708 · Received December 6, 2018

    Report

    Report Number
    3010606081-2018-00020
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    November 8, 2018
    Report Date
    December 5, 2018
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE CUSTOMER CONTACTED DARIO TO REPORT A HIGH BLOOD GLUCOSE READING (500MMOL/L). PRIOR TO CONTACTING DARIO, THE CUSTOMER WENT TO THE HOSPITAL DUE TO A MIXTURE OF HEALTH PROBLEMS, INCLUDING FAILURE TO MONITOR HIS BLOOD GLUCOSE LEVELS ON A REGULAR BASIS, WHICH HE MENTIONS IS HIS OWN FAULT. THE USER WAS TESTED AT THE HOSPITAL AND HIS BLOOD GLUCOSE LEVELS WERE DIFFERENT FROM WHEN HE TESTED HIMSELF AT HOME AFTER HE GOT BACK FROM THE HOSPITAL. DUE TO THE DIFFERENCE BETWEEN THE HOSPITAL READING AND THE READING HE GOT AT HOME WITH THE DARIO METER, HE CONTACTED US FOR HELP. IT WAS CONCLUDED IN THE INVESTIGATION THAT THE CUSTOMER WAS USING EXPIRED STRIPS AS THEY WERE OPEN FOR OVER 30-DAYS. STRIP LOT # 16Y16A1. PER USER GUIDE, THE STRIPS SHOULD NOT BE USED AFTER A MONTH OF BEING OPENED. ADDITIONALLY, THE CUSTOMER WAS USING AN UNSUPPORTED DEVICE (I-PAD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976606 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD. 1021-02 1608231

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization