BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA 2 METER

    MDR report key: 2037610 · Received March 31, 2011

    Report

    Report Number
    MW5019999
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 21, 2011
    Manufacturer
    LIFESCAN
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FALSE LOW BLOOD GLUCOSE RESULTS. (USED ONE TOUCH ULTRA 2 METER AND TEST STRIPS FROM LIFE SCAN, INC. (B)(4)) -- PURCHASED FROM (B)(6) PHARMACY, (B)(6). LOT NO: 3112626; EXP DATE: 08/01/2012. FREQUENCY: CHECK BLOOD GLUCOSE TWICE DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA 2 METER METER NBW LIFESCAN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR