BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 7478756 · Received May 2, 2018

    Report

    Report Number
    3010606081-2018-00005
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    March 12, 2018
    Report Date
    May 2, 2018
    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

    Additional Manufacturer Narrative · 1

    IN CONCLUSION, USER HAD ELEVATED BLOOD GLUCOSE READING WHEN HE MEASURED HIS BLOOD GLUCOSE WITH DARIO. USER SOUGHT MEDICAL TREATMENT AND WAS TREATED FOR ELEVATED BLOOD GLUCOSE READINGS. USER PERFORMED TWO CONTROL SOLUTION TESTS, AND BOTH WERE IN RANGE. LEVEL M (RANGE 102-147 MG/DL) AND RESULT WAS 128 MG/DL. LEVEL H (RANGE 182-262 MG/DL) AND RESULT WAS 233 MG/DL. DEVICE NOT REQUESTED FOR INVESTIGATION AS DEVICE WAS FOUND TO FUNCTION ACCORDING TO SPECIFICATIONS AND FAILURE MODE WAS NOT CONFIRMED. IN ADDITION TO THAT, USER DESIRED TO CONTINUE MEASURING BLOOD GLUCOSE WITH DARIO.

    Description of Event or Problem · 1

    ON (B)(6) 2018 CUSTOMER CONTACTED DARIO TO REPORT SLIGHTLY ELEVATED BLOOD GLUCOSE READINGS COMPARED TO HIS OTHER BLOOD GLUCOSE METER. USER REPORTED STRIPS WERE STORED IN KITCHEN. PER USER GUIDE (PAGE 12), IT STATES "DO NOT STORE THE METER OR TEST STRIPS IN AN AREA WHERE THE HUMIDITY IS OUTSIDE OF THE RANGE 10-90%, SUCH AS A BATHROOM OR KITCHEN". CUSTOMER WAS SENT CONTROL SOLUTION AND NEW TEST STRIPS TO VERIFY ACCURACY OF METER AND STRIPS. ON (B)(6) 2018 USER PERFORMED CONTROL SOLUTION TESTS AND RESULTS WERE IN RANGE. USER ALSO CHECKED BLOOD GLUCOSE LEVELS AND REPORTED READING OF 395 MG/DL WITH DARIO COMPARED TO 358 MG/DL WITH USE OF ANOTHER METER. CUSTOMER WAS ADVISED TO SEEK PHYSICIAN TREATMENT IMMEDIATELY. ON (B)(6) 2018 USER INFORMED DARIO THAT HE WAS SENT TO THE EMERGENCY ROOM AS BLOOD GLUCOSE LEVELS WERE ABOVE 300 MG/DL. USER REPORTED MEDICAL TREATMENT WAS PROVIDED TO BRING BLOOD GLUCOSE DOWN. IN ADDITION TO THAT, USER STATED BLOOD GLUCOSE REMAINED HIGH FOR ABOUT 2 DAYS UNTIL NEW MEDICATION CAME INTO EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323832 DARIO BLOOD GLUCOSE MONITORING SYSTEM SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LABSTYLE INNOVATIONS LTD. 1021-02 1707221

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization