BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 8373384 · Received February 27, 2019

    Report

    Report Number
    3010606081-2019-00005
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    January 31, 2019
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE READINGS. SHE REPORTED SHE WENT TO THE ER DUE TO THE HIGH READINGS. WHEN IN THE HOSPITAL, THEY TESTED HER BLOOD GLUCOSE AND IT WAS FOUND IN ORDER. THE USER REPORTED SHE WAS USING AN ADAPTOR TO CONNECT DARIO AUDIO METER WITH HER (B)(6). DARIO BLOOD GLUCOSE MONITORING SYSTEM IS NOT CURRENTLY CLEARED FOR USAGE WITH A (B)(6) ADAPTER. WE HAVE NOT TESTED THE DARIO WITH ANY (B)(6) CONVERTERS OR ADAPTERS AND DO NOT HAVE DATA TO SUPPORT THIS USAGE - THIS WAS EXPLAINED TO THE USER. SHE WAS ADVISED IT IS NOT RECOMMENDED TO USE THE DARIO METER WITH ANY CONVERTER OR ADAPTER IN ORDER TO ENSURE ACCURATE BLOOD GLUCOSE READINGS. WHILE TALKING TO DARIO REPRESENTATIVE, THE USER WAS INSTRUCTED TO OPEN A NEW CARTRIDGE IN ORDER TO INVESTIGATE WHETHER THE ISSUE WAS DUE TO THE STRIPS USED. THE USER TRIED AGAIN WITH A NEW PACK OF STRIPS. SHE TESTED WITH CONTROL SOLUTION - BOTH LEVEL 1 AND LEVEL 2 WERE ABOVE THE RANGE OF CONTROL SOLUTION. THE USER THEN WENT TO URGENT CARE CLINIC TO CHECK HER BLOOD GLUCOSE - THE READING WAS NORMAL RANGE. THE USER THEN CALLED BACK TO REPORT THIS. IT WAS CONCLUDED THE HIGH READINGS WERE DUE TO THE USE OF ADAPTER WITH (B)(6). THE USER WAS SENT A NEW DARIO (B)(6) METER COMPATIBLE TO HER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169157 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD. 1021-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization