BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA MINI METER

    MDR report key: 6913926 · Received October 4, 2017

    Report

    Report Number
    MW5072578
    Event Type
    Injury
    Date Received
    October 4, 2017
    Date of Event
    October 2, 2017
    Report Date
    October 2, 2017
    Manufacturer
    LIFE SCAN
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY BLOOD GLUCOSE METER IS GIVING INCORRECT READINGS. I USE A ONE TOUCH MINI BLOOD GLUCOSE METER. RECENTLY, I HAVE BEEN EXPERIENCING LOW BLOOD SUGAR FOLLOWING BOLUS BASED ON THE BLOOD GLUCOSE READINGS. I TESTED THE METER WITH CONTROL SOLUTION FROM LOT NUMBER 8A2A83 WHICH GAVE A READING OF 212. ACCORDING TO THE BLOOD STRIP CONTAINER. THE TOP OF THE SPECIFICATION IS 157 MG/DL. I NOTICED THAT THE CONTROL SOLUTION WAS OUT OF SPEC, SO I PERFORMED A TEST WITH ANOTHER METER BY FIRST DISPENSING THE CONTROL SOLUTION ONTO A PLATE AND SAMPLING FROM THIS SAMPLE BY BOTH METERS. AS NOTED, THE MINI MED READING WAS OUT OF SPEC. THE OTHER METER WAS IN-SPEC AT 147MG/DL. I CALLED CUSTOMER SERVICE BUT THEY COULD NOT UNDERSTAND THAT I HAVE ELIMINATED THE SOLUTION AS A SOURCE OF THE ERROR. OF COURSE, THIS IS A SERIOUS ISSUE GIVEN THAT DIABETICS BOLUS ACCORDING TO THESE READINGS. I SUSPECT THIS ISSUE HAS BEEN CAUSING LOW-BLOOD SUGAR IN MY HOME OF 3 TYPE 1 DIABETICS INCLUDING MYSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694135 ONE TOUCH ULTRA MINI METER ONE TOUCH ULTRA MINI METER NBW LIFE SCAN ULTRA MINI METER

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other