BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 362724 · Received November 20, 2001

    Report

    Report Number
    2939301-2001-00936
    Event Type
    Malfunction
    Date Received
    November 20, 2001
    Report Date
    October 12, 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

    A PT REPORTED EXPERIENCING INACCURATE HIGH RESULTS WITH AN OT PROFILE METER. THE PT'S BLOOD GLUCOSE WAS 201, 147, AND 128 WITH A 27% DIFFERENCE. TESTS WERE DONE WITHIN 10 MINUTES. PT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFO HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52748 ONE TOUCH PROFILE BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR