BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1071024 · Received July 2, 2008

    Report

    Report Number
    2939301-2008-01281
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Report Date
    June 14, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 RESULT IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THE CONTROL SOLUTION TEST WAS FALLING ABOVE THE INDICATED CONTROL RANGE. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE WALKED THE LAY USER THROUGH A CONTROL SOLUTION TEST AND THE RESULT FELL OUTSIDE THE SPECIFIED CONTROL SOLUTION RANGE. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2733761

    Patients

    Seq Age Sex Outcome Treatment
    1