BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1082687 · Received July 22, 2008

    Report

    Report Number
    2939301-2008-01480
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Report Date
    June 26, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACT LIFESCAN ALLEGING THAT THE ONE TOUCH ULTRALINK METER HAD THE FOLLOWING UNRESOLVED BUTTONS/SCANNERS ISSUE: (DOWN ARROW BUTTON). 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 NA