BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 8411449 · Received March 12, 2019

    Report

    Report Number
    3010606081-2019-00008
    Event Type
    Injury
    Date Received
    March 12, 2019
    Date of Event
    February 13, 2019
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE READINGS. PRIOR TO CONTACTING DARIO, THE USER HAD A VERY LOW BLOOD GLUCOSE READING OF 59 AND WENT TO THE ER. AT THE HOSPITAL, THEY TESTED HER BLOOD GLUCOSE AND THE READING WAS 126. THE USER REPORTED SHE WAS AT THE ER ONLY FOR A FEW HOURS AND THAT SHE WAS PUT ON IV WITH GLUCOSE. WHILE ON THE CALL WITH DARIO, THE USER WAS TRAINED ON BLOOD GLUCOSE MEASURING USING THE DARIO METER AND STRIPS. DURING THE TRAINING, THE USER SAID THAT SHE DOESN'T REPLACE THE WHOLE CARTRIDGE. SHE ALWAYS MOVES STRIPS FROM THE NEW CARTRIDGE TO THE OLD ONE. IN ADDITION, THE USED CARTRIDGE WAS OPEN OVER 30 DAYS. AS PER LABELING, UNUSED TEST STRIPS SHOULD BE STORED IN THEIR ORIGINAL CARTRIDGE AND STRIPS SHOULD BE USED WITHIN 30 DAYS FROM OPENING A NEW CARTRIDGE. THE USER WAS INSTRUCTED TO OPEN A NEW CARTRIDGE OF TEST STRIPS. THE ISSUE WAS RESOLVED WITH THE NEW STRIPS. NO DEVICE PROBLEM WAS DETECTED; NOT ENOUGH INFORMATION REGARDING THE INITIALLY USED STRIPS TO INVESTIGATE. THE USER DID NOT CALL BACK FOR FURTHER ASSISTANCE. FOLLOW UP ATTEMPT WITH THE CUSTOMER WAS MADE, HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204461 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD. 1021-02 1707051

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization