BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1083663 · Received July 24, 2008

    Report

    Report Number
    2939301-2008-00882
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Report Date
    May 15, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT STRIPS FOR EVAL, 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/PT CONTACTED LIFESCAN ALLEGING THAT THE PRODUCT WAS PROMPTING THE "ERROR 5" MESSAGE. DURING THE TROUBLESHOOTING THE CUSTOMER CARE ADVOCATE (CCA) FOUND OUT THAT THE TESTING TECHNIQUES WERE CORRECT. IT IS NOT KNOWN WHETHER THE TEST STRIPS WERE IN GOOD CONDITION. WHEN RETESTED WITH A NEW VIAL OF TEST STRIPS THE ISSUE WAS RESOLVED. THE PATIENT'S TEST STRIPS WERE REPLACED. 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 2818451

    Patients

    Seq Age Sex Outcome Treatment
    1