BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 20331813 · Received September 30, 2024

    Report

    Report Number
    3010606081-2024-00060
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 5, 2024
    Report Date
    September 30, 2024
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    UDI-DI
    00850065006154
    PMA / PMN Number
    K150817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TROUBLESHOOTING ON THE PHONE WITH DARIO'S REPRESENTATIVE, IT WAS DETERMINED THAT THE USER STILL RECEIVED HIGH BG READINGS EVEN THOUGH SHE USED A NEW CARTRIDGE OF STRIPS. THE USER HAS REQUESTED TO CALL HER BACK AT A LATER TIME. 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 (B)(6), THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING BG READINGS OF APPROXIMATELY 190 MG/DL FROM HER DARIO METER COMPARED TO A RANGE OF 110 MG/DL TO 120 MG/DL THAT SHE RECEIVED FROM HER NON-DARIO METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061111 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD. 1021-04 NA 00850065006154

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other