BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA MINI

    MDR report key: 8444073 · Received March 21, 2019

    Report

    Report Number
    MW5085078
    Event Type
    Injury
    Date Received
    March 21, 2019
    Date of Event
    March 19, 2019
    Report Date
    March 19, 2019
    Manufacturer
    LIFESCAN SCOTLAND LTD.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE ONE TOUCH ULTRA MINI GLUCOSE METER TEST PROVIDES AN INACCURATE READING THAT COULD HAVE RESULTED IN ME GOING ON INSULIN UNNECESSARILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234726 ONE TOUCH ULTRA MINI SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LIFESCAN SCOTLAND LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R