BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 377673 · Received February 5, 2002

    Report

    Report Number
    2939301-2002-01726
    Event Type
    Other
    Date Received
    February 5, 2002
    Report Date
    January 5, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    METER NAME: ONE TOUCH PROFILE, STRIP NAME: LIFESCAN, METER CODE: 7, STRIP CODE: UNKNOWN, STRIP STORAGE: UNKNOWN, SYMPTOMS: DROWSY AND SYMPTOMS OF LOW LEVEL. A PATIENT REPORTED THEY WERE SEEN BY THE ENDOCRINOLOGIST. THEIR METER ALLEGEDLY WAS INACCURATELY HIGH. THE RESULT ON THEIR METER WAS 391, 372, 312, AND 391 (NO UNITS). THE RESULT ON THE ENDOCRINOLOGIST METER WAS UNKNOWN. THE TIME DIFFERENCE BETWEEN PATIENT'S METER AND ENDOCRINOLOGIST WAS UNKNOWN. TREATMENT WAS UNKNOWN. ENDOCRINOLOGIST CHANGED MEDICATION DUE TO INCIDENT. 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 64 YR Required Intervention