BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 18592775 · Received January 27, 2024

    Report

    Report Number
    3010606081-2023-00102
    Event Type
    Malfunction
    Date Received
    January 27, 2024
    Date of Event
    December 27, 2023
    Report Date
    December 27, 2023
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE ON THE PHONE WITH DARIO'S REPRESENTATIVE, IT WAS DETERMINED THAT THE USER TOUCHED THE YELLOW TESTING SITE WHILE TESTING HER BG LEVEL. DARIO'S USER GUIDE STATES IN THE SECTION TEST STRIP PRECAUTIONS: "DO NOT TOUCH THE YELLOW TESTING SITE WHEN HANDLING THE TEST STRIP". DARIO'S USER GUIDE ALSO STATES IN THE SECTION FACTORS THAT MAY LEAD TO INACCURATE RESULTS: "INCORRECT TESTING TECHNIQUE OR IMPROPER STORAGE OR HANDLING OF THE DARIO SYSTEM MAY ALSO LEAD TO INACCURATE TEST RESULTS WHICH ARE INCONSISTENT WITH HOW YOU FEEL." 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. AFTER THE NEW DARIO STRIPS AND CONTROL SOLUTION WERE RECEIVED, DARIO'S REPRESENTATIVE FOLLOWED UP WITH THE USER. THE USER'S NEWER DARIO METER WAS TESTED WITH CONTROL SOLUTION AND A NEW CARTRIDGE OF STRIPS: THE METER READ WITHIN RANGE FOR BOTH TESTS. CONTROL SOLUTION LEVEL 1 TEST RESULTS WAS 144 MG/DL (RANGE 107-155 MG/DL) CONTROL SOLUTION LEVEL 2 TEST RESULTS WAS 236 MG/DL (RANGE 183-264 MG/DL) THE USER ALSO TESTED HER BG LEVEL WITH THE NEW CARTRIDGE OF STRIPS AND RECEIVED A READING OF 100 MG/DL, WHICH THE USER REPORTED IS IN RANGE FOR HER. THE INCONSISTENT AND HIGH BG READINGS MAY HAVE BEEN DUE TO MISUSE OF THE STRIPS. THERE IS NOT ENOUGH INFORMATION REGARDING THE METER AND OLD STRIPS AVAILABLE TO FURTHER INVESTIGATE THIS CASE. THEREFORE, NO RESOLUTION IS AVAILABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE USER CONTACTED DARIO TO REPORT INCONSISTENT AND HIGH BLOOD GLUCOSE (BG) READINGS. THE USER, WHO HAS TWO DARIO METERS, REPORTED THAT WITHIN A SPAN OF TEN MINUTES, SHE RECEIVED FROM ONE OF HER DARIO METERS BG READINGS OF 221 MG/DL, 267 MG/DL, 363 MG/DL AND 560 MG/DL FROM ONE FINGER, AND 99 MG/DL (TWICE), AND 104 MG/DL FROM HER OTHER FINGER. THE READINGS WERE TAKEN APPROXIMATELY 2 MINUTES APART. THE USER ADDED THAT ON ONE OF THE BG READING ATTEMPTS, SHE DID NOT RECEIVE A READING, BUT A MESSAGE SAYING "CONTACT YOUR DOCTOR IMMEDIATELY". THE USER ALSO REPORTED THAT ON THE 9TH OF JANUARY, WHEN SHE TESTED HER BG LEVEL WITH HER OTHER NEWER DARIO METER AND A NEW CARTRIDGE OF STRIPS, SHE RECEIVED A BG READING OF 98 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649232 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other