BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCH METER - ULTRAMINI + ULTRA 2

    MDR report key: 1820755 · Received August 27, 2010

    Report

    Report Number
    MW5017246
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    April 1, 2010
    Report Date
    August 18, 2010
    Manufacturer
    LIFESCAN, INC
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INACCURATE GLUCOSE METER READINGS WITH NEW METER AS COMPARED TO FORMER METER. DOSE OR AMOUNT: CHECK SUGAR. FREQUENCY: 4X/ DAILY. ROUTE: FINGER PRICK. DATES OF USE: (B)(6)2010 - PRESENT. DIAGNOSIS OR REASON FOR USE: DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCH METER - ULTRAMINI + ULTRA 2 ONETOUCH METER - ULTRAMINI + ULTRA 2 NBW LIFESCAN, INC ULTRA MINI AW06404803A
    2 CONTOUR BLOOD GLUCOSE MONITORING SYSTEM CONTOUR BLOOD GLUCOSE MONITORING SYSTEM NBW BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Life Threatening| O