BEUDAMED
    FDA Adverse Event Death Summary report: N

    OT ULTRA TEST STRIPS

    MDR report key: 844738 · Received April 18, 2007

    Report

    Report Number
    2939301-2007-00285
    Event Type
    Death
    Date Received
    April 18, 2007
    Date of Event
    August 19, 2006
    Report Date
    March 21, 2007
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FDA DID NOT PROVIDED THE METER TYPE OR SERIAL NUMBER TO LIFESCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2634145

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death