BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 11998870 · Received June 15, 2021

    Report

    Report Number
    3010606081-2021-00016
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 4, 2021
    Report Date
    June 15, 2021
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON MAY 4TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. PRIOR TO CONTACTING DARIO, THE USER REPORTED FEELING UNWELL, SO SHE TESTED HER BG LEVEL AND RECEIVED A READING OF 366 MG/DL. THE USER REPORTED THAT AN HOUR LATER, SHE AGAIN TESTED HER BG LEVEL AND RECEIVED A READING OF 359 MG/DL. DUE TO HER NOT FEELING WELL, AND THE ABOVE ELEVATED READINGS, THE USER WENT TO THE ER WHERE HER BG LEVEL WAS TESTED WITH THE HOSPITAL'S METER AND WAS FOUND TO READ 72 MG/DL COMPARED TO A READING OF 326 MG/DL WITH THE USER'S DARIO METER. MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE USER WERE MADE, HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THERE IS NOT ENOUGH INFORMATION AVAILABLE TO FURTHER INVESTIGATE THIS CASE. THEREFORE, NO RESOLUTION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897936 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization