BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 19939176 · Received August 8, 2024

    Report

    Report Number
    3010606081-2024-00047
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 4, 2024
    Report Date
    August 8, 2024
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TROUBLESHOOTING ON THE PHONE WITH DARIO'S REPRESENTATIVE, IT WAS DETERMINED THAT THE USER WAS USING A CARTRIDGE OF STRIPS THAT WAS OPEN FOR WELL OVER 30 DAYS AND WAS THEREFORE EXPIRED. DARIO'S USER GUIDE STATES IN THE SECTION PRECAUTIONS: "DO NOT USE A TEST STRIP EXPIRED 1 MONTH FROM OPENING. DISCARD THE CARTRIDGE 1 MONTH AFTER OPENING". IN ADDITION, IT WAS ALSO DETERMINED THAT THE USER WAS USING A CARTRIDGE OF STRIPS THAT HAD EXPIRED IN (B)(6) 2024. DARIO'S USER GUIDE STATES IN THE SECTION FACTORS THAT MAY LEAD TO INACCURATE RESULTS: "THE TEST STRIP IS EXPIRED." AND IN THE TEST STRIP PRECAUTIONS SECTION: "CHECK THE "USE BY" DATE ON THE TEST STRIP CARTRIDGE. DO NOT USE THE TEST STRIPS AFTER THAT DATE". THE USER ALSO REPORTED STORING HER CARTRIDGE OF STRIPS IN THE KITCHEN. DARIO'S USER GUIDE STATES IN THE SECTION OF GENERAL PRECAUTIONS: "DO NOT STORE THE METER OR TEST STRIPS IN AN AREA WHERE THE HUMIDITY IS OUTSIDE OF THE RANGE 10-90%, SUCH AS A BATHROOM OR KITCHEN." A REPLACEMENT OF DARIO'S STRIPS AND CONTROL SOLUTION WAS SENT TO THE USER TO MAKE SURE THAT THE DARIO STRIPS ARE READING CORRECTLY, AND TO ENSURE PROPER TECHNIQUE. MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE USER WERE MADE, HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THE HIGH BG READINGS WERE MOST LIKELY DUE TO THE MISUSE OF THE STRIPS. THERE IS NOT ENOUGH INFORMATION REGARDING THE METER AVAILABLE TO FURTHER INVESTIGATE THIS CASE. THEREFORE, NO RESOLUTION IS AVAILABLE.

    Description of Event or Problem · 0

    ON JULY 11TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS.THE USER, WHO IS NOT DIABETIC, REPORTED RECEIVING HIGH BG READINGS FOR A WEEK, REACHING OVER 300 MG/DL. DUE TO THE ABOVE, THE USER WENT TO THE EMERGENCY ROOM WHERE HER BG WAS TESTED AND FOUND TO BE 86 MG/DL, WHICH THE USER STATED IS NORMAL FOR HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069318 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Other| H