BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 480317 · Received August 20, 2003

    Report

    Report Number
    2939301-2003-06407
    Event Type
    Malfunction
    Date Received
    August 20, 2003
    Report Date
    August 15, 2003
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THAT HE KEPT GETTING ERROR 1 ON THEIR ONE TOUCH PROFILE METER. MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE PT ON 8/19/2003 AND THEY STATED THAT THEY STARTED GETTING THIS ERROR ON THE SAME DAY HE REPORTED IT. SINCE PT WAS UNABLE TO CHECK THEIR BLOOD GLUCOSE, THEY VISITED THEIR DR. THEY DID NOT REMEMBER THE RESULT ON THE DR'S METER, BUT DID STATED THAT THEY WERE NOT TREATED WITH ANYTHING. THEY ALSO STATED THAT THEY DO NOT TAKE ANY INSULIN AT HOME. PT WAS EXPERIENCING BLURRY VISION PRIOR TO TESTING ON THE METER AND GETTING THE ERROR MESSAGES. THE ERROR 1 ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THIS CASE IS BEING REPORTED AS A METER MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR