BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 378053 · Received February 15, 2002

    Report

    Report Number
    2939301-2002-02630
    Event Type
    Malfunction
    Date Received
    February 15, 2002
    Report Date
    January 23, 2002
    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

    A PATIENT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A ONE TOUCH PROFILE METER. IN 2002 THE PATIENT'S BLOOD GLUCOSE RESULTS WERE 112, 345, AND 366 MG/DL. TESTS WERE DONE 11-20 MINUTES APART. TWO WEEKS LATER, THE PATIENT'S BLOOD GLUCOSE RESULTS WERE 91, 243 AND 157 MG/DL. TESTS WERE DONE 11-20 MINUTES APART. PATIENT DID NOT EXPERIENCE ANY ADVDRSE EVENTS. 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 84 YR