BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO GLUCOSE METER

    MDR report key: 11321614 · Received February 11, 2021

    Report

    Report Number
    MW5099363
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Report Date
    February 10, 2021
    Manufacturer
    DARIOHEALTH CORP. / LABSTYLE INNOVATIONS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN HAVING ONGOING, REPETITIVE PROBLEMS WITH THE DARIO GLUCOSE METER. OVER THE PAST 5 OR MORE YEARS, DARIO HAS HAD TO REPLACE THE METER ABOUT ONCE A YEAR. THE PROBLEM IS NOT WITH THE METER ITSELF - IT'S WITH THE HOUSING IN WHICH THE METER IS CONTAINED. SPECIFICALLY, THE END CAPS OF THE METER HOUSING CRACK AND SPLIT. DARIO ONLY WARRANTS THE METER FOR ONE YEAR, SO ON ONE OR TWO OCCASIONS I'VE HAD TO PURCHASE A NEW METER - EVEN THOUGH THE ISSUE IS RESTRICTED TO THE ORANGE AND WHITE END CAPS THAT COVER, ON ONE HAND, THE STORAGE COMPARTMENT FOR TEST STRIPS AND, ON THE OTHER, THE LANCING DEVICE. IT WOULD BE MUCH SIMPLER (AND LESS COSTLY FOR ALL) TO SIMPLY REPLACE THE END CAPS - BUT DARIO DOESN'T DO THIS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214430 DARIO GLUCOSE METER SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW DARIOHEALTH CORP. / LABSTYLE INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1