BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 8844807 · Received July 31, 2019

    Report

    Report Number
    3010606081-2019-00020
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 8, 2019
    Report Date
    July 31, 2019
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE USER WIFE CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. SHE INDICATED THAT PRIOR TO CONTACTING DARIO, HER HUSBAND WAS GETTING HIGH BG LEVELS WITH DIFFERENCES OF UP TO 400 MG/DL, AND WAS DOSING INSULIN INCORRECTLY AS PER THE HIGH BG READINGS. THE USER HAS 4 DARIO METERS. USER WIFE REPORTED ALL 4 METERS WERE READING HIGH. THE USER BG READING RANGE IS 130 TO 210 MG/DL. IN THE PAST 2 MONTHS, HIS BG READINGS WITH THE DARIO METERS RANGE FROM 300 UP TO 476 MG/DL. THE USER WIFE REPORTED HE WAS OVERDOSING INSULIN DUE TO THE HIGH BG READINGS. PRIOR TO THE CALL TO DARIO, THE USER WENT TO THE DOCTOR BECAUSE HE WAS NOT COHERENT, WAS SWEATING, COULDN'T WALK AND COULD NOT TALK. AT THE DOCTOR, IT BECAME CLEAR THE USER HAD A HYPOGLYCEMIC EVENT AS HIS BG READING WAS 47 MG/DL. HOWEVER, ON THAT DAY, DARIO METERS MEASUREMENTS WERE HIGH ALL DAY. DURING THE CALL WITH DARIO SUPPORT, THE USER WIFE REFUSED TO GIVE DETAILS OF THE 4 METERS AND STRIPS AND REFUSED TO TROUBLESHOOT. ON (B)(6) 2019, DARIO TIER2 CONTACTED THE USER AND SENT RMAS FOR ALL 4 METERS. ON (B)(6) 2019, THE METERS WERE RECEIVED AND TESTED: 1ST METER HAD A CONFIRMED SAMPLE READING ISSUE. SINCE THIS METER WASN'T IN ORDER, IT COULD NOT HAVE READ HIGH. 2ND, 3RD AND 4TH METERS READ HIGHER THAN THE CONTROL SOLUTION RANGE. IT WAS CONCLUDED THE COMPLAINT IS CONFIRMED WITH REGARDS TO THE 2ND, 3RD AND 4TH METERS, AND FURTHER INVESTIGATION IS REQUIRED. THE THREE METERS THAT READ HIGH WILL BE RETURNED TO LABSTYLE INNOVATION LTD. FOR R&D INVESTIGATION.,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642159 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD. 1021-02 1902251, 1804171, 1811261

    Patients

    Seq Age Sex Outcome Treatment
    1 Other