BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 377890 · Received January 31, 2002

    Report

    Report Number
    2939301-2002-01234
    Event Type
    Other
    Date Received
    January 31, 2002
    Report Date
    November 14, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    METER NAME: PROFILE. STRIP NAME: ONE TOUCH. METER CODE: UNKNOWN. STRIP CODE: UNKNOWN. STRIP STORAGE: UNKNOWN. SYMPTOMS: CAN'T STAY AWAKE. FEELING TIRED. A PATIENT REPORTED THEY HAD DROPPED THE METER A COUPLE TIMES THE PAST WEEK AND NOW CANNOT GET PAST THE NOT OK MESSAGE AND CANNOT TEST FOR TWO DAYS NOW. THEIR METER ALLEGEDLY WOULD ONLY PROMPT MESSAGE NOT OK. THE RESULT ON THEIR METER WAS UNKNOWN. THE RESULT ON THE NONE. THE TIME DIFFERENCE BETWEEN PATIENT'S METER: NO COMPARISON. TREATMENT: NOT TREATMENT. 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 UNKNOWN