BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1232079 · Received November 7, 2008

    Report

    Report Number
    2939301-2008-02989
    Event Type
    Malfunction
    Date Received
    November 7, 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
    AL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO 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 THERE WAS AN ERROR 5 ISSUE WITH THE ONE TOUCH ULTRALINK METER. THE PT ALLEGED HE HAD A "HIGH SYMPTOM" SOMETIME BEFORE THE ISSUE BEGAN. HE TOOK HIS USUAL DOSE OF INSULIN DUE TO THE ISSUE. THE PT DENIED SEEKING MEDICAL ATTENTION. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE TEST STRIPS WERE IN GOOD CONDITION. THE PT'S TESTING TECHNIQUE WERE INCORRECT. THE PRODUCT WAS NOT NEW (OUT OF BOX). THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE SYMPTOMS THE PT ALLEGED HAPPENED BEFORE THE PRODUCT ISSUE BEGAN.

    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