BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA TEST STRIPS

    MDR report key: 10465309 · Received August 27, 2020

    Report

    Report Number
    MW5096315
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    August 22, 2020
    Report Date
    August 26, 2020
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ONE TOUCH ULTRA GLUCOSE STRIPS LOT 4580171 GIVES WILDLY INACCURATE READINGS AT HIGH GLUCOSE LEVELS MY DEXCOM G6 AND A DIFFERENT LOT BOTH READ 174-177, WHILE 3 CHECKS FROM THE PROBLEM LOT READ FROM 222- 258 I CONTACTED LIFESCAN CUSTOMER SERVICE, BUT THEY JUST SENT ME A FORM EMAIL BACK. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928006 ONE TOUCH ULTRA TEST STRIPS SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LIFESCAN, INC. 4580171
    928007 ONE TOUCH ULTRA TEST STRIPS SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LIFESCAN, INC. 4580171
    928008 ONE TOUCH ULTRA TEST STRIPS SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LIFESCAN, INC. 4580171

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR