BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 20071526 · Received August 26, 2024

    Report

    Report Number
    3010606081-2024-00050
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 26, 2024
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    ON JULY 26TH, THE USER CONTACTED DARIO TO REPORT A HIGH BLOOD GLUCOSE (BG) READING. THE USER REPORTED RECEIVING FROM HER DARIO METER A BG READING THAT WAS 70 MG/DL HIGHER THAN HER OTHER BG METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18348 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other