BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONTE TOUCH PROFILE

    MDR report key: 658227 · Received December 27, 2005

    Report

    Report Number
    2939301-2005-05920
    Event Type
    Malfunction
    Date Received
    December 27, 2005
    Report Date
    December 20, 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 PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "51, 81, 97, AND 93 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONTE TOUCH PROFILE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 244077A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN