BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 662907 · Received January 6, 2006

    Report

    Report Number
    2939301-2006-00091
    Event Type
    Malfunction
    Date Received
    January 6, 2006
    Report Date
    December 30, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED BLOOD GLUCOSE RESULTS OF "100, 159, AND 152 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. THE METER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PROFILE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 267697A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN