BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH BASIC ENHANCED

    MDR report key: 390279 · Received February 20, 2002

    Report

    Report Number
    2939301-2002-02739
    Event Type
    Malfunction
    Date Received
    February 20, 2002
    Report Date
    January 28, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED THAT THEY TOOK INSULIN WITHOUT CONSULTING THEIR PHYSICIAN BECAUSE THEY COULDN'T GET A READING FROM THE METER. THE PATIENT'S METER ALLEGEDLY WOULD ONLY PROMPT THE NOT OK MESSAGE. THE PATIENT WAS UNABLE TO GE A READING ON THEIR METER. THERE WAS NO COMPARISON. THE PATIENT TOOK INSULIN WITHOUT CONSULTING WITH THEIR PHYSICIAN. THE PATIENT WENT OUT AND BOUGHT AN OT ULTRA METER. A READING OF 211 MG/DL IS DOCUMENTED (UNCLEAR IF THE TEST WAS DONE ON OT ULTRA METER). NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR