BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH II

    MDR report key: 416292 · Received April 8, 2002

    Report

    Report Number
    2939301-2002-04987
    Event Type
    Malfunction
    Date Received
    April 8, 2002
    Report Date
    March 20, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED THEIR ONE TOUCH II METER ALLEGEDLY WOULD NOT POWER ON. THE RESULTS ON THEIR METER WAS 74, 151, 109 AND 137MG/DL. TREATMENT WAS MEDICATION FOR DIABETES. NO FURTHER INFO HAS BEEN REPORTED. NO SERIOUS INJURY OR ALLEGATION OF HARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR