BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1162863 · Received September 9, 2008

    Report

    Report Number
    2939301-2008-02044
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Report Date
    August 11, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION PT'S AGE AND GENDER IS UNAVAILABLE.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THE PRODUCT WAS PROMPTING THE ERROR 1 MESSAGE, WHICH WAS UNRESOLVED WITH TROUBLESHOOTING. THE PATIENT INDICATED THAT THE METER WAS EXPOSED TO WATER. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1