BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC

    MDR report key: 236974 · Received August 20, 1999

    Report

    Report Number
    2939301-1999-00650
    Event Type
    Injury
    Date Received
    August 20, 1999
    Date of Event
    July 23, 1999
    Report Date
    July 24, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRIOR TO 07/23/1999, THE PT HAS BEEN OBTAINING METER READINGS AROUND 120 MG/DL ON HIS ONE TOUCH BASIC METER. ON 07/23/1999, HE REPORTS EVERY RESULT ON HIS METER WAS IN THE "40'S." BECAUSE HE FELT ILL, HE WENT TO THE HOSP WHERE HIS BLOOD SURGAR WAS "OVER 500." THE PT WAS ADMITTED AND TREATED FOR HYPERGLYCEMIA AND RELEASED ON 07/25/1999. HE REPORTED THAT THE METER IS CLEANED ONLY WHEN IT DISPLAYS THE "CLEAN TEST AREA" PROMPT AND QUALITY CHECKS ARE PERFORMED ONCE A MONTH OR LESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R