BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIO ONE TOUCH GLUCOMETER

    MDR report key: 8772564 · Received July 8, 2019

    Report

    Report Number
    MW5087953
    Event Type
    Injury
    Date Received
    July 8, 2019
    Date of Event
    July 1, 2019
    Report Date
    July 3, 2019
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USING VERIO AND VERIO FLEX GLUCOMETERS RECEIVED VARYING RESULTS WITH A RANGE OF 100 MG/DL. ON MULTIPLE TESTINGS WITHIN ONE MIN ON (B)(6) 2019 GOT READINGS WITH A RANGE OF 240-340 AND ON (B)(6) 2019 READINGS RANGED FROM 129-209 AND 131-186 ERRONEOUS READINGS ON (B)(6) CAUSED EXCESS INSULIN ADMINISTRATION RESULTING IN HYPOGLYCEMIA. BLOOD GLUCOSE 62. TEST STRIPS WERE NEW, EXPIRE 08/31/2020. BECAUSE OF THE VARIATION I PURCHASED A NEW METER AND TESTED THE TWO METERS AGAINST EACH OTHER. EACH TIME ANALYZING BLOOD FROM THE SAME FINGER. BELOW ARE THE RESULTS - NEW METER VERIO, OLD METER VERIO FLEX 209: 147 162 186 129 131. ALL THESE TESTS WERE DONE WITHIN 4 MINS AND EACH HORIZONTAL LINE WAS DONE ON THE SAME FINGER STICK. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559927 VERIO ONE TOUCH GLUCOMETER SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LIFESCAN, INC. X1811875X
    559928 VERIO FLEX GLUCOMETER SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LIFESCAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR