BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIO FLEX ONETOUCH

    MDR report key: 17135910 · Received June 14, 2023

    Report

    Report Number
    MW5118414
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    June 10, 2023
    Report Date
    June 12, 2023
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    KAISER "RECOMMENDS" THE VERIO ONETOUCH BLOOD GLUCOSE METER. I HAD TO GET IT WHEN MY (SUPERIOR) METER'S TEST STRIPS WERE NO LONGER COVERED. I ORIGINALLY STOPPED USING THIS METER BECAUSE OF ITS INACCURACY BUT WAS FORCED TO GET IT AGAIN. I JUST DID A TEST WHERE MY CGM READING WAS 167 AND THE READINGS FOR THE TEST STRIP WERE: 143, 152, 169, 147 AND 163. THE LAST 4 WERE DONE WITH THE EXACT SAME DROP OF BLOOD. DIABETICS DEPEND ON THESE METERS FOR EITHER THEIR MAIN DEVICE OR BACKUP FOR THEIR CGM, LIKE I DO, WHICH CAN ALSO BE OFF AT TIMES. FOR THIS METER TO BE THIS OFF, PUTS DIABETICS AT RISK. IF THERE WAS A SCENARIO WHERE MY CGM READ LOW, AND I DOUBLE CHECKED WITH THIS AND IT READ NORMAL, I COULD GO INTO A DIABETIC COMA IF I DIDN'T KNOW TO TREAT THE LOW BLOOD SUGAR. SEE SCANNED PAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2103290 VERIO FLEX ONETOUCH SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LIFESCAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female DEXCOM CGM| INSULIN| LEVOTHYROXINE