BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 472665 · Received July 14, 2003

    Report

    Report Number
    2939301-2003-00273
    Event Type
    Malfunction
    Date Received
    July 14, 2003
    Report Date
    July 2, 2003
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT REPORTED EXPERIENCING AN ERROR 5 ON THEIR OT ULTRA METER. THEY DID NOT EXPERIENCE ANY SYMPTOMS OF LOW OR HIGH BLOOD SUGAR. THEY DO NOT MODIFY THEIR MEDICATION ACCORDING TO THE METER READING, ONLY AFTER THEIR DR HAS PRESCRIBED THE CHANGE. THEY CONTINUED TO TAKE THEIR INSULIN AND ORAL MEDICATION AS USUAL. THEY TAKE 36 UNITS OF R AND 44 UNITS OF N IN THE MORNING, 16 UNITS OF R AND 18 UNITS OF N IN THE EVENING. THEY ALSO TAKE 500 MG OF METFORMIN TWICE A DAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN