BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 7998399 · Received October 24, 2018

    Report

    Report Number
    3010606081-2018-00015
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    September 25, 2018
    Report Date
    October 24, 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

    USER'S DAUGHTER CONTACTED DARIO TO REPORT HER MOTHER HAD RECEIVED HIGH READINGS WITH THE DARIO METER. AS A RESULT, PROVIDER INSTRUCTED USER TO INCREASE INSULIN DOSAGE. USER TAKES INSULIN VIA A SLIDING SCALE METHOD. OVER THE WEEKEND, USER NOTIFIED PROVIDER THAT BLOOD SUGAR REMAINS HIGH. SHE WAS SENT TO A CLINIC FOR A BLOOD AND URINE TEST. BLOOD TEST RESULTS WERE PENDING, HOWEVER, AT HOME BLOOD SUGAR WAS FOUND TO BE APPROXIMATELY 290MD/DL. AT LUNCH USER ADMINISTERED INSULIN. FOLLOWING THAT, USER WAS SWEATING, COULD NOT WALK, AND WAS CONFUSED. USER WAS TAKEN TO EMERGENCY ROOM. AT EMERGENCY ROOM BLOOD SUGAR WAS 99MG/DL. USING THE DARIO METER, IT WAS OVER 300MG/DL. LAB RESULTS FROM THE AFTERNOON REVEALED BLOOD SUGAR OF 45 MG/DL. CONTROL SOLUTION HAS BEEN SENT TO THE USER TO DETERMINE ACCURACY OF METER. USER HAS YET TO PROVIDE RESULTS. IN ADDITION, DEVICE HAS BEEN REQUESTED FOR INVESTIGATION. DEVICE HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840080 DARIO BLOOD GLUCOSE MONITORING SYSTEM SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LABSTYLE INNOVATIONS LTD. 1021-02 1608271

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization