BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1082363 · Received July 24, 2008

    Report

    Report Number
    2939301-2008-01516
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Report Date
    June 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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/PATIENT CONTACTED LIFESCAN (LFS) IN 2008 ALLEGING BLACK MARKS ON THE PATIENT'S ONE TOUCH ULTRA LINK METER. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE. THERE WAS NO METER TRAUMA. THE METER IS NOT A NEW PRODUCT (OUT OF BOX). METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED DUE TO THE BLACK MARKS ON THE PATIENT'S METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2814123

    Patients

    Seq Age Sex Outcome Treatment
    1 NP