BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 663602 · Received September 15, 2005

    Report

    Report Number
    2939301-2005-04048
    Event Type
    Malfunction
    Date Received
    September 15, 2005
    Report Date
    September 6, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    METER WAS SET TO THE INCORRECT UNIT OF MEASUREMENT. THE PATIENT NOTICED THE METER WAS READING IN MMOL/L SO SHE WENT TO THE LOCAL DIABETES CLINIC FOR ASSISTANCE. NO BLOOD GLUCOSE RESULTS WERE REPORTED, NOR WAS ANY MEDICAL INTERVENTION REQUIRED. THE ANSWERS TO THE QUESTIONS ASKED BY CUSTOMER SERVICE, INDICATES THE PATIENT TOOK INSULIN. HER MEDICATIONS WERE CHANGED DURING THE VISIT TO THE CLINIC. NO SYMPTOMS WERE REPORTED. HER METER WAS PREVIOUSLY SET TO THE CORRECT UNIT OF MEASUREMENT. SHE HAD NOT MADE ANY CHANGES TO THE UNIT OF MEASUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2560988

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR