BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1243824 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03226
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 17, 2008
    Report Date
    November 17, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE REPORTER (PATIENT'S MOTHER) CONTACTED LIFESCAN (LFS) ON BEHALF OF THE LAY USER/ PATIENT ALLEGING THAT THE ONE TOUCH ULTRASMART KEPT ON DISPLAYING "APPLY BLOOD." THE REPORTED ISSUE FIRST OCCURRED EARLY AT 7:30 AM IN 2008 (SAME DAY THE PATIENT CONTACTED LFS). BY 12:30 PM THE SAME DAY, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF "HIGH" BLOOD GLUCOSE LEVELS. THE SPECIFICS OF THE "HIGH" SYMPTOMS WERE NOT REPORTED. USUALLY, THE PATIENT TESTS 6 TIMES PER DAY BUT BECAUSE OF THE REPORTED ISSUE, THE PATIENT REPORTEDLY WAS UNABLE TO TEST ALL DAY. AT 6 PM THE SAME DAY (ABOUT 20 MINUTES BEFORE THE PATIENT'S MOTHER CONTACTED LFS), THE PATIENT ALLEGEDLY GUESSED HOW MUCH INSULIN TO TAKE AND TOOK 6 UNITS OF HUMALOG. NORMALLY, THE PATIENT BASES HER INSULIN DOSAGES ON HER METER READINGS AND FOOD INTAKE. IT IS UNKNOWN IF THE PATIENT'S SYMPTOMS WERE RELIEVED OR WORSENED AFTER TAKING THE 6 UNITS OF INSULIN. NO OTHER FORMS OF TREATMENT WERE REPORTED. THE CUSTOMER CARE ADVOCATE WENT THROUGH TROUBLESHOOTING WITH THE PATIENT AND NOTED THAT THE TEST STRIPS WERE NOT DRAWING IN THE SAMPLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE PROVIDED INFORMATION, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY BECAME HYPERGLYCEMIC AFTER NOT BEING ABLE TO OBTAIN A TEST RESULT ON HER METER. IN ADDITION, THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2676398

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening