BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 378355 · Received February 4, 2002

    Report

    Report Number
    2939301-2002-01121
    Event Type
    Injury
    Date Received
    February 4, 2002
    Report Date
    November 28, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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: FREQUENT URINATION. THE CUSTOMER WENT TO ER DUE TO AN INFECTION IN LEG. STATED THAT IF METER WAS GIVING CORRECT READINGS, CUSTOMER WOULD HAVE A SIGN THAT BLOOD SUGAR WAS OUT OF CONTROL. THEIR METER ALLEGEDLY WAS READING INACCURATELY ERRATIC AND LATER FOUND HAD MISSING SEGMENTS. THE METER ON THEIR METER 240, 200, 131. THE TIME DIFFERENCE BETWEEN PT'S METER AND NO COMPARISON. TREATMENT WAS: REGULAR MEDICATION. NO FURTHER INFO 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 59 YR Hospitalization| R