BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNISTRIP GENERIC

    MDR report key: 5949184 · Received September 12, 2016

    Report

    Report Number
    MW5064735
    Event Type
    Malfunction
    Date Received
    September 12, 2016
    Date of Event
    August 31, 2016
    Report Date
    September 12, 2016
    Manufacturer
    UNISTRIP TECHNOLOGIES, LLC
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DIABETIC SUPPLY FROM MEDICARE WAS CHANGED FROM ONE TOUCH ULTRA SENSOR STRIP TO UNISTRIP GENERIC. I EXPERIENCED THE 10 - 15 PERCENT LOWER SUGAR LEVEL COMPARED TO THE BRANDED STRIP (ONE TOUCH ULTRA). IN ADDITION, I CHECKED UNISTRIP WITH THEIR SOLUTION. THE READINGS WERE BETWEEN 49-56 WITH THREE STRIPS WITH ERROR. THE TOTAL VARIATION CAUSED BY UNISTRIP IS 25 - 30 PERCENT TO THE BRANDED ONE TOUCH ULTRA. THIS UNISTRIP IS JUNK. FDA SHOULD NOT APPROVE SUCH POOR QUALITY/UNSAFE PRODUCT FOR CONSUMER USE, PARTICULARLY DIABETIC PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596014 UNISTRIP GENERIC UNISTRIP GENERIC NBW UNISTRIP TECHNOLOGIES, LLC U15091612

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR