BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONT TOUCH BASIC ENCHANCED

    MDR report key: 338316 · Received June 19, 2001

    Report

    Report Number
    2939301-2001-00531
    Event Type
    Injury
    Date Received
    June 19, 2001
    Date of Event
    May 19, 2001
    Report Date
    May 19, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PAIENT REPORTED GETTING LOW INACCURATE RESULTS WHILE USING A ONE TOUCH METER. ON EVENT DATE, PATIENT'S BLOOD GLUCOSE WAS 40MG/DL ON OT METER AT 02:00AM. PATIENT DRANK AND TESTED AGAIN AT 02:25AM AND THEIR BLOOD GLUCOSE WAS 36MG/DL. AT 02:40 AM PATIENT WENT TO THE EMERGENCY ROOM WHERE THEIR BLOOD GLUCOSE WAS 200MG/DL ON UNKNOWN METER. PATIENT HAS NOT REPORTED EXPERIENCING ANY ADVERSE EVENT SYMPTOMS. PATIENT HAD VISITED THE EMERGENCY ROOM TO VERIFY OT METER READING. LIFESCAN REPRESENTATIVE CONTACTED PATIENT FOR FURTHER INFORMATION. DURING THE CONTACT, THE OT FAILED THE CONTROL TEST. PATIENT REPORTEDLY CLEANS METER WITH ALCOHOL WHICH IS A PRACTICE WARNED AGAINST IN THE OT OWNER'S MANUAL. NO ALLEGATIONS OF HARM HAVE BEEN MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27895 ONT TOUCH BASIC ENCHANCED BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention GLUCOPHAGE, GLUCOTROL, NORVASC, HYZAAR.