BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1082868 · Received July 25, 2008

    Report

    Report Number
    2939301-2008-01544
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Report Date
    July 3, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 ALLEGING THAT THE PRODUCT WAS PROMPTING THE APPLY SAMPLE ISSUE. THE CUSTOMER CARE ADVOCATE WALKED THE LAY USER THROUGH THE TROUBLESHOOTING AND FOUND OUT THAT THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE. THE TEST STRIP DREW THE SAMPLE INTO THE TEST AREA AND WHEN RETESTED WITH A NEW VIAL OF TEST STRIPS, THE ISSUE WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. 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 2822397

    Patients

    Seq Age Sex Outcome Treatment
    1