BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 8243013 · Received January 13, 2019

    Report

    Report Number
    3010606081-2018-00026
    Event Type
    Injury
    Date Received
    January 13, 2019
    Date of Event
    December 13, 2018
    Report Date
    January 13, 2019
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE CUSTOMER CONTACTED DARIO TO REPORT BLOOD GLUCOSE READINGS ARE INCONSISTENT. THE PATIENT IS THE CUSTOMER'S DAD. SHE TOOK HIS BLOOD GLUCOSE READING AND GOT 51 MG/DL. HE ATE AND THEN ACTED CRAZY AND THE READING WAS 124 MG/DL. THEY WENT TO THE EMERGENCY ROOM, WHERE HE TESTED 25 MG/DL. THE CUSTOMER WENT HOME AND BROUGHT DARIO METER BACK TO HOSPITAL. DARIO WAS 60 MG/DL AND ANOTHER METER TESTED 90 MG/DL. THE DOCTOR TOLD THEM THE DEVICE MAY NOT BE READING CORRECTLY. THE CUSTOMER WAS UPSET AND DID NOT WANT TO TEST THE METER, ONLY DEMANDED TO REPLACE IT. THE CUSTOMER WAS SENT RMA: A REPLACEMENT METER AND AN ENVELOPE TO RETURN THE OLD METER TO TEST IT. RMA NOT RECEIVED UP TO THE DATE OF THIS REPORT. NOT ENOUGH INFORMATION REGARDING THE OLD METER TO INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35789 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD. 1021-04 1806071

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization