BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 372886 · Received January 15, 2002

    Report

    Report Number
    2939301-2002-00488
    Event Type
    Malfunction
    Date Received
    January 15, 2002
    Report Date
    December 27, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A FASTTAKE METER. THE PATIENT'S BLOOD GLUCOSE RESULTS WERE 218, 160, 198 MG/DL. THE TIME BETWEEN EACH TEST IS UNKNOWN. THE AVERAGE OF THE THREE IS 18%. THE AVERAGE BETWEEN 218 AND 160 IS 27MG. THE AVERAGE OF THE OTHERS IS LESS THAN 20%. THE CUSTOMER REFUSED TO TROUBLESHOOT OR ANSWER THE ADDITONAL QUESTION FOR THE CUSTOMER CARE REPRESENTATIVE. NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN