BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 8389341 · Received March 5, 2019

    Report

    Report Number
    3010606081-2019-00007
    Event Type
    Injury
    Date Received
    March 5, 2019
    Date of Event
    February 6, 2019
    Report Date
    March 5, 2019
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE USER CONTACTED DARIO TO CONSULT REGARDING INCONSISTENT BLOOD GLUCOSE READINGS. PRIOR TO CONTACTING DARIO, THE USER VISITED HIS DOCTOR IN ORDER TO DOUBLE CHECK HIS BLOOD GLUCOSE LEVELS BECAUSE OF THE INCONSISTENT READINGS. WHILE ON THE CALL WITH DARIO, THE USER WAS TRAINED ON BLOOD GLUCOSE MEASURING USING THE DARIO METER. IN ADDITION, HE 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. AS PER DARIO SYSTEM LOGS, THE USER KEPT USING HIS DARIO METER TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182271 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD. 1021-02 1803171

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization