BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 8207335 · Received January 1, 2019

    Report

    Report Number
    3010606081-2018-00024
    Event Type
    Injury
    Date Received
    January 1, 2019
    Date of Event
    December 7, 2018
    Report Date
    January 1, 2019
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE CUSTOMER CONTACTED DARIO BY EMAIL TO REPORT BLOOD GLUCOSE READINGS "25-30 POINTS HIGHER" THAN WHAT HE THINKS THEY SHOULD BE, COMPARED TO HIS RELION METER. IN THE EMAIL, THE CUSTOMER MENTIONED TWO TIMES IN THE PAST IN WHICH THE METER READ OVER 150 POINTS, SO HE TOOK 2 UNITS OF HUMALOG AS PRESCRIBED. BOTH TIME HE DROPPED TO BELOW 30. THE CUSTOMER STATED THAT IN BOTH THOSE INCIDENTS HIS WIFE HAD TO CALL AN AMBULANCE BECAUSE SHE COULDN'T WAKE HIM UP. THE CUSTOMER REPORTED THESE TWO INCIDENTS TO DARIO A MONTH BEFORE, DURING A PHONE-CALL ON (B)(6) 2018. AT THAT TIME HE TOLD DARIO THAT HE GOT A READING OF 185 MG/DL AND TOOK 2 UNITS OF INSULIN. HE "CRASHED" BUT DIDN'T SEEK HELP FROM PHYSICIAN WHEN THAT HAPPENED - HE DRANK ORANGE JUICE AND GOT BETTER. HE MENTIONED ON THAT CALL THAT PARAMEDICS WERE CALLED. THE CUSTOMER TESTED WITH CONTROL SOLUTION TO VERIFY ACCURACY OF METER AND STRIPS . THE METER READ WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD. 1021-04 1805281

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other