BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 7841754 · Received September 4, 2018

    Report

    Report Number
    3010606081-2018-00012
    Event Type
    Injury
    Date Received
    September 4, 2018
    Date of Event
    August 7, 2018
    Report Date
    September 4, 2018
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STRIP INFORMATION: LOT #17Z14A1 .EXPIRATION DATE: 08/09/2019. DATE STRIPS OPENED: (B)(6) 2018. ONCE CARTRIDGE OF STRIPS OPEN - EXPIRES WITHIN 30 DAYS. PER TEST STRIPS IFU ("UPON OPENING THE TEST STRIPS CARTRIDGE, WRITE DATE OF OPENING IN THE DESIGNATED SPACE ON THE CARTRIDGE. TEST STRIPS CAN BE USED FOR 1 MONTH FROM THE FIRST TIME THE CARTRIDGE IS EXTRACTED FROM ITS FOIL POUCH. DO NOT USE TEST STRIPS BEYOND THIS PERIOD").

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE USER'S MOM CONTACTED DARIO TO REPORT HER SON WAS TAKEN TO THE HOSPITAL FOR HIGH BLOOD GLUCOSE READINGS. BG READING AT HOSPITAL WAS 212 MG/DL (HOSPITAL METER). USER THEN CHECKED BG READING WITH DARIO AND READING WAS 345 MG/DL. IN THE INITIAL INVESTIGATION IT WAS FOUND THAT THE CUSTOMER HAD USED EXPIRED TEST STRIPS (CARTRIDGE OPENED IN (B)(6) 2018). SINCE THE EVENT,USER OPENED A NEW CARTRIDGE OF STRIPS AND REPORTS METER IS READING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682606 DARIO BLOOD GLUCOSE MONITORING SYSTEM SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER, NBW LABSTYLE INNOVATIONS LTD. 1021-02 1712061

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization