BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1071025 · Received July 2, 2008

    Report

    Report Number
    2939301-2008-01280
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Report Date
    June 13, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF THE STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE STRIPS DO 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 ERROR 5 MESSAGE, WHICH WAS RESOLVED WHEN THE PATIENT TESTED WITH A NEW VIAL OF TEST STRIPS. HOWEVER, THE ERROR MESSAGE WAS NOT RESOLVED WHEN USING INITIAL VIAL OF TEST STRIPS. 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 2786155

    Patients

    Seq Age Sex Outcome Treatment
    1