BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA-MINI

    MDR report key: 7086695 · Received December 5, 2017

    Report

    Report Number
    MW5073753
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    November 1, 2017
    Report Date
    December 5, 2017
    Manufacturer
    LIFESCAN
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED FIRST METER GAVE HIGH READINGS, 800 - 900. SECOND METER WAS SENT TO CUSTOMER. WHEN STRIPS WERE INSERTED, METER DISPLAYED 3 LINE AND FAILED TO PERFORM READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863826 ONE TOUCH ULTRA-MINI GLUCOMETER NBW LIFESCAN
    863827 ONE TOUCH ULTRA-MINI GLUCOMETER NBW LIFESCAN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR