BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE TOUCH ULTRA TEST STRIPS

    MDR report key: 811221 · Received January 31, 2007

    Report

    Report Number
    MW4004268
    Event Type
    Death
    Date Received
    January 31, 2007
    Date of Event
    August 19, 2006
    Report Date
    October 18, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT REPORTED HER HUSBAND DIED OF UNCONTROLLED DIABETES IN 2006. COMPLAINANT BECAME AWARE OF THE WARNING/PRESS RELEASE FROM FDA ON ONE-TOUCH ULTRA TEST STRIPS. COMPLAINANT HUSBAND USED ONE-TOUCH ULTRA STRIPS FROM LIFESCAN, INC. NO LOT # WAS GIVEN BUT STATED IT WAS THE NUMBER IN THE FDA WARNING. HUSBAND WAS UNDER THE CARE OF DR. UNK WHETHER DR HAS FILED A MED-WATCH FOR THIS INCIDENT. COMPLAINANT HAS MEDICAL RECORDS AND REMAINING PRODUCT ON HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA TEST STRIPS * NBW LIFESCAN, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death