BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 704761 · Received November 23, 2005

    Report

    Report Number
    2939301-2005-05375
    Event Type
    Malfunction
    Date Received
    November 23, 2005
    Report Date
    November 20, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED BLOOD GLUCOSE RESULTS (MG/DL) OF "463, 351, 248, 402, 337, 252, 260, AND 240" WITH A LIFESCAN METER, PERFORMED GREATER THAN 20 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 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2581844

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN