BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY METER

    MDR report key: 2395848 · Received January 3, 2012

    Report

    Report Number
    2939301-2012-00017
    Event Type
    Injury
    Date Received
    January 3, 2012
    Report Date
    January 3, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 510K#:K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE LAY USER/PATIENT IN ITALY CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAEASY METER WAS GIVING INACCURATE READINGS. THE (B)(4) WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON AN UNSPECIFIED DATE AT 8:00 AM THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 200 MG/DL AND 110 MG/DL OVER A TIME PERIOD GREATER THAN 20 MINUTES. BASED ON THE 200 MG/DL READING, THE PATIENT TOOK HIS USUAL DOSE OF TEN UNITS INSULIN, TYPE NOT SPECIFIED. AT 9:00 AM THE PATIENT EXPERIENCED THE SYMPTOMS OF LIGHTHEADEDNESS AND FAINTING. AT 9:15 AM, WHILE SYMPTOMATIC, THE PATIENT TESTED HIS BLOOD GLUCOSE LEVEL TO BE 41 MG/DL, USING ANOTHER METER. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING SUGAR; HE DID NOT SEEK ANY MEDICAL ATTENTION. THE METER WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS AND BLOOD GLUCOSE READINGS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON AN ELEVATED METER READING, AND RECEIVED TREATMENT WITH FOOD. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA EASY METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3177675

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R