BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH II

    MDR report key: 595001 · Received January 24, 2003

    Report

    Report Number
    2939301-2003-00762
    Event Type
    Malfunction
    Date Received
    January 24, 2003
    Report Date
    January 24, 2003
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN