BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 18198698 · Received November 23, 2023

    Report

    Report Number
    3010606081-2023-00076
    Event Type
    Malfunction
    Date Received
    November 23, 2023
    Date of Event
    October 24, 2023
    Report Date
    October 24, 2023
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 STORING HER CARTRIDGE OF STRIPS IN THE BATHROOM. 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." IT WAS ALSO DETERMINED THAT THE USER WAS USING ALCOHOL SWABS TO CLEAN HER FINGER BEFORE TESTING. DARIO'S USER GUIDE STATES IN THE SECTION FACTORS THAT INTERFERE WITH BLOOD GLUCOSE TESTING "ALCOHOL CAN AFFECT TEST RESULTS". 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 DARIO METER WAS TESTED WITH CONTROL SOLUTION AND A NEW CARTRIDGE OF STRIPS: THE METER READ WITHIN RANGE ONLY FOR THE LEVEL 2 TEST. CONTROL SOLUTION LEVEL 1 TEST RESULTS WAS 157 MG/DL (RANGE 107-155 MG/DL) CONTROL SOLUTION LEVEL 2 TEST RESULTS WAS 252 MG/DL (RANGE 183-264 MG/DL). THE USER ALSO TESTED HER BG LEVEL AND RECEIVED A BG READING OF 109 MG/DL, WHICH THE USER STATED WAS IN RANGE FOR HER. MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE USER AND RETEST WITH THE CONTROL SOLUTION WERE MADE, HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THE 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 HIGH BLOOD GLUCOSE (BG) READINGS.THE USER REPORTED THAT PRIOR TO CONTACTING DARIO, SHE RECEIVED A BG READING OF 170 MG/DL FROM HER DARIO METER COMPARED TO A BG READING OF 103 FROM HER NON-DARIO METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230765 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other