BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC

    MDR report key: 235409 · Received August 13, 1999

    Report

    Report Number
    2939301-1999-00575
    Event Type
    Injury
    Date Received
    August 13, 1999
    Date of Event
    July 9, 1999
    Report Date
    July 15, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 07/09/1999 AT 6/P, THE PT, FEELING UNWELL, TESTED HER BLOOD GLUCOSE ON HER ONE TOUCH BASIC WITH A RESULT OF 209 MG/DL. UNSURE IF HER HYPERTENSION OR BLOOD SUGAR WERE CAUSING HER TO FEEL ILL, SHE TESTED ON A NEIGHBOR'S ONE TOUCH METER AT 6:30/P WITH A RESULT OF 445 MG/DL. BETWEEN 8/P AND 9/P, THE PT WAS TESTED AT THE HOSPITAL (HOSPITAL METER, BRAND UNK) WITH A RESULT OF 495 MG/DL. SHE WAS TREATED WITH R INSULIN AND ADMITTED FOR HYPERGLYCEMIA AND HYPERTENSION. THE METER IS NOT CLEANED ACCORDING TO MFR'S RECOMMENDATIONS, ALCOHOL IS USED TO CLEAN THE METER OPTICS. CALIBRATION STATUS IS UNK AT THIS TIME.

    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 47 YR Required Intervention