BEUDAMED
    FDA Adverse Event Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 758562 · Received November 8, 2005

    Report

    Report Number
    MW4004054
    Date Received
    November 8, 2005
    Report Date
    October 11, 2005
    Manufacturer
    LIFESCAN SCOTLAND LTD
    Product Code
    NBW
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SYSTEM WOULD NOT READ PROPERLY. AN 'ERROR 4' MESSAGE DISPLAYS ON SCREEN. PT STATED THAT SHE RECEIVED THE UNIT (A SAMPLE) FROM HER PHYSICIAN. SHE CALLED THE NUMBER ON THE BOX & WAS SENT A SECOND UNIT, WHICH HAD THE SAME PROBLEM. LIFESCAN'S (JOHNSON & JOHNSON) CUSTOMER CARE ADVOCATE STATED THAT THERE HAD BEEN A LEVEL I RECALL ON THE PRODUCT BACK IN APRIL OR MAY 2005 DUE TO A POSSIBLE ISSUE WITH THE METER'S DISPLAY, HOWEVER, HE STATED THAT THEY HAD NOTIFIED ALL CONSUMERS BY LETTER AND REPLACED ALL UNITS SUBJECT TO RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM NBW LIFESCAN SCOTLAND LTD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *