BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 8314084 · Received February 7, 2019

    Report

    Report Number
    3010606081-2019-00002
    Event Type
    Injury
    Date Received
    February 7, 2019
    Date of Event
    January 10, 2019
    Report Date
    February 7, 2019
    Manufacturer
    LABSTYLE INNOVATIONS LTD
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. HE REPORTED HIS PHYSICIAN SEND HIM TO THE EMERGENCY ROOM, WHERE HIS BLOOD GLUCOSE READING WAS 144. DARIO READINGS WERE 572 AND LATER 412. WHEN TALKING TO THE USER, HE STATED THE STRIPS WERE OPEN 6 MONTHS AGO - MEANING HE WAS USING EXPIRED STRIPS. THE COMPLAINT FAILURE MODE WAS NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109543 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD 1021-02 1612131

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization