BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 249905 · Received November 12, 1999

    Report

    Report Number
    2939301-1999-01029
    Event Type
    Injury
    Date Received
    November 12, 1999
    Date of Event
    October 10, 1999
    Report Date
    October 12, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT'S BLOOD GLUCOSE LEVELS WERE HIGH ON 10/09/1999 (251, 273 MG/DL). HER BLOOD GLUCOSE WAS NORMAL FOR THE NEXT TWO DAYS, YET SHE FELT ILL WITH NAUSEA AND VOMITING. HER BLOOD GLUCOSE ON HER ONE TOUCH PROFILE METER AT LUNCH TIME SUNDAY WAS 100 MG/DL. SHE WAS TRANSPORTED TO THE HOSP AT 10:30PM AFTER OBTAINING A BLOOD GLUCOSE RESULT OF 84 MG/DL. A LAB TEST UPON ARRIVAL WAS 1,100 MG/DL. SHE WAS ADMITTED AND TREATED FOR HYPERGLYCEMIA. THE RPTR STATED THAT IN LOOKING BACK AT THE METER MEMORY FOR THE PAST 3 DAYS, THE PT'S BLOOD GLUCOSE RESULTS HAD CHECK MARKS NEXT TO THEM, INDICATING A CHECK STRIP RESULT AND NOT A BLOOD GLUCOSE RESULT. IT WAS UNKNOWN TO THE RPTR AT TIME OF THIS REPORT THAT THE CHECK MARK WAS NOT A BLOOD GLUCOSE RESULT. TRAINING WAS PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R