BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1220807 · Received October 30, 2008

    Report

    Report Number
    2939301-2008-02906
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Report Date
    October 27, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION. LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PT CONTACTED LFS ALLEGING INTERMITTENT ISSUE WITH THE OK BUTTON. THE PT WAS UNABLE/UNWILLING TO VERIFY WHETHER THEY EXHIBITED ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. THE PT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HIS OR HER PHYSICIAN DUE TO THE REPORTED ISSUE. THE METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2860776

    Patients

    Seq Age Sex Outcome Treatment
    1