BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1220869 · Received October 30, 2008

    Report

    Report Number
    2939301-2008-02890
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Report Date
    October 24, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCTS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR TEST STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE ONE TOUCH ULTRALINK METER WAS GIVING THE ERROR 5 ERROR MESSAGE. THE PATIENT REPORTED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS, AND ALSO DID NOT REPORT SEEKING ANY MEDICAL ATTENTION. THE PATIENT REFUSED TO COMPLETE TROUBLESHOOTING THE ISSUE. THE METER AND TEST STRIPS WERE REPLACED. THE ISSUE WAS NOT RESOLVED. THE PATIENT DID NOT SUFFER ANY INJURY DUE TO THE REPORTED METER. THE PATIENT REPORTED NO SYMPTOMS OR MEDICAL ATTENTION. HOWEVER, AS THE ERROR 5 MESSAGE ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2855607

    Patients

    Seq Age Sex Outcome Treatment
    1