BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVOO TEST STRIPS

    MDR report key: 16530449 · Received March 10, 2023

    Report

    Report Number
    MW5115691
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    March 7, 2023
    Report Date
    March 8, 2023
    Manufacturer
    VIVOSENS BIYOTEKNOLOJI AR-GE, SAN. & TIC. LTD. STI
    Product Code
    LJX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USED VIVOO TEST STRIPS AND WAS TOLD THAT I HAD PROTEIN IN MY URINE. I DID NOT ON TWO OTHER DIPSTICKS. WAS PUSHED DUE TO LOW MAGNESIUM/CALCIUM TO BUY A VITAMIN THEY SELL. HAD MY HUSBAND ALSO DO IT, AND HE WAS GIVEN IDENTICAL RESULTS TO MINE, ALSO PUSHED TO BUY THE PRODUCT. I THEN TESTED IT USING A GLASS OF RO WATER (I AM A SCIENTIST AND HAVE ACCESS TO A LAB), IT SAID THE WATER ALSO HAD HIGH PROTEIN AND WAS PUSHED TO BUY THE SUPPLEMENT. I DONT BELIEVE THESE TEST STRIPS WORK AND THEY ARE MAKING HEALTH RECS THOUGH THEY SAY THEY ARE NOT AND ARE NOT FDA APPROVED. REFERENCE REPORT MW5115690.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836701 VIVOO TEST STRIPS TEST, URINE LEUKOCYTE LJX VIVOSENS BIYOTEKNOLOJI AR-GE, SAN. & TIC. LTD. STI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown