BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 8193107 · Received December 23, 2018

    Report

    Report Number
    3010606081-2018-00023
    Event Type
    Injury
    Date Received
    December 23, 2018
    Date of Event
    December 19, 2018
    Report Date
    December 23, 2018
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE CUSTOMER CONTACT DARIO TO REPORT BLOOD GLUCOSE READINGS ARE HIGHER THAN THEY SHOULD BE FOR HIM. THE CUSTOMER JUST RECEIVED THE DARIO METER. HE DID THE FIRST READING AFTER HE DIDN'T CHECK IN A LONG TIME. THE READING WAS ABOVE 600, HE CALLED HIS PHYSICIAN, WHO SENT HIM TO THE EMERGENCY ROOM. READING THERE WAS 500 CONFIRMED THE DARIO METER READING. HE STAYED IN THE ER FOR 4 HOURS UNTIL STABILIZED. THE HOSPITAL READING CONFIRMED THE HIGH READING ON THE DEVICE WAS CORRECT. AFTER RETURNING HOME HE CHECKED AND READING WAS HIGHER THAN EXPECTED. HE OPENED NEW STRIPS CARTRIDGE AND THE ISSUE WAS RESOLVED; READINGS WERE IN ORDER. STRIPS AND METER LABELING WERE REVIEWED; NO NON-CONFORMANCE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032334 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD. 1021-04 1811151

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization