BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1232176 · Received November 4, 2008

    Report

    Report Number
    2939301-2008-02949
    Event Type
    Malfunction
    Date Received
    November 4, 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
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVAL, 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

    IN 2008, THE LAY USER/PT CONTACTED LIFESCAN ALLEGING THE ONE TOUCH ULTRALINK METER SHOWED THE APPLY SAMPLE MESSAGE. THE PT DENIED SUFFERING ANY SYMPTOMS. THE PT DID NOT TAKE ANY ACTION REGARDING TREATMENT DUE TO THE ISSUE. THE PT DENIED SEEKING MEDICAL ATTENTION. IT WAS DETERMINED DURING THE TROUBLESHOOTING TELEPHONE CALL, THE PT'S TESTING TECHNIQUE WAS CORRECT. THE PRODUCT WAS NOT NEW (OUT OF BOX). THE TEST STRIPS DID DRAW THE SAMPLE INTO THE TEST AREA. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PT DID NOT SUFFER ANY SYMPTOMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1