BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 377879 · Received January 31, 2002

    Report

    Report Number
    2939301-2002-01182
    Event Type
    Other
    Date Received
    January 31, 2002
    Report Date
    November 13, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    METER NAME: ONE TOUCH PROFILE. STRIP NAME. UNKNOWN. METER CODE: UNKNOWN. STRIP CODE: UNKNOWN. STRIP STORAGE: UNKNOWN. SYMPTOMS: YELLOW EYES, FREQUENT URINATION. A PATIENT REPORTED THEY WERE UNABLE TO TEST ON THE METER. THEIR METER ALLEGEDLY WOULD ONLY PROMPT THE NOT OK MESSAGE. UNABLE TO OBTAIN A READING ON THE METER. NO COMPARISON. NOT TREATED. CUSTOMER HAD TO GUESS AMOUNT OF INSULIN. NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other