BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH BASIC ENHANCED

    MDR report key: 577880 · Received February 3, 2004

    Report

    Report Number
    2939301-2004-00725
    Event Type
    Malfunction
    Date Received
    February 3, 2004
    Report Date
    January 30, 2004
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED BLOOD GLUCOSE RESULTS OF 90 MG/DL AND 127 MG/DL WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EAH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BASIC ENHANCED GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 207023A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN