BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA MINI TEST STRIPS

    MDR report key: 3820106 · Received May 15, 2014

    Report

    Report Number
    MW5036125
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM DIABETIC AND USE THE ONE TOUCH ULTRA MINI TO TEST MY BLOOD. FOR THE PAST THREE WEEKS MY NUMBERS HAVE BEEN HIGHER THEN NORMAL. JUST THIS MORNING I TESTED THREE TIMES AND HAD THREE DIFFERENT RESULTS. THE NUMBERS WERE 142, 113 AND 154. SOMETHING IS GOING ON WITH THE STRIPS. I CAN'T CHANGE THEM BECAUSE MY INSURANCE COMPANY ONLY ALLOWS ONE TOUCH. DOSE OR AMOUNT: TEST 3 TIMES A DAY. FREQUENCY: THREE TIMES DAILY. DATES OF USE: (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: TEST BLOOD SUGAR LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292220 ONE TOUCH ULTRA MINI TEST STRIPS ONE TOUCH ULTRA MINI TEST STRIPS CGA 3606095

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability