BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1203706 · Received October 9, 2008

    Report

    Report Number
    2939301-2008-02615
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Report Date
    October 6, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE LAY USER/PT CONTACTED LIFESCAN ALLEGING THAT THE PRODUCT WAS PROMPTING THE "ERROR 5" MESSAGE, WHICH WAS UNRESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. THE TEST STRIPS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2828462

    Patients

    Seq Age Sex Outcome Treatment
    1