BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA STRIP 100S

    MDR report key: 1275487 · Received October 21, 2008

    Report

    Report Number
    MW5009437
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 6, 2008
    Manufacturer
    LIFESCAN
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT STATES BOX ARRIVED AND WAS SEALED AND INTACT BUT ONE CONTAINER IN BOX WAS OPENED, THIS IS NOT FIRST TIME THIS HAS HAPPENED TO PT OTHER CONTAINER WITH LOT 2841929 EXP 12-2009 ARRIVED WITH 1 CONTAINER OPENED AND PATIENT TRIED STRIPS AND GOT HIGH BLOOD SUGAR READINGS - 134 AND WHEN RECHECKED IT WAS ACTUALLY 102. DOSE, FREQUENCY AND ROUTE USED: USE AS DIRECTED. THERAPY DATES: EARLY 2007 TO PRESENT. DIAGNOSIS FOR USE: DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA STRIP 100S ONE TOUCH ULTRA STRIP 100S NBW LIFESCAN 2871939
    2 ONE TOUCH ULTRA STRIP 100S ONE TOUCH ULTRA STRIP 100S NBW LIFESCAN 2841929

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR