BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3141440 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14144
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 9, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH HER ONETOUCH ULTRA2 METER TESTING IN THE SETTINGS MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013, AT 9AM. THE PATIENT DOES NOT TAKE MEDICATIONS TO MANAGE HER DIABETES AND CONTINUED TO FOLLOW HER USUAL MANAGEMENT ROUTINE. A COUPLE HOURS AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE FELT A SYMPTOM OF DIZZY. BY 1130AM THAT SAME MORNING, THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM (ER) AND OBTAINED A BLOOD GLUCOSE RESULT OF ¿43 MG/DL¿ WITH THE ER/ HOSPITAL METER. THE PATIENT WAS GIVEN FOOD AND/ OR DRINK AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA EDUCATED THE PATIENT ON THE CORRECT TESTING PROCEDURE AND WALKED HER THROUGH A RETEST TO RESOLVE THE ALLEGED ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245418 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3440559

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R