BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1242245 · Received November 19, 2008

    Report

    Report Number
    2939301-2008-03188
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 3, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 PATIENT/LAYPERSON ALLEGED THAT THE ONETOUCH ULTRA2 METER PROMPTED APPLY SAMPLE IN 2008 AT 5PM WHEN ATTEMPTING TO TEST. THIRTY MINUTES AFTER THE REPORTED ISSUE BEGAN, THE PATIENT INDICATED SHE WAS "SHAKY WITH BLURRED VISION." THE PATIENT REPORTEDLY ATE MORE FOOD AFTER THE ISSUE. CUSTOMER SERVICE REPLACED THE METER AND TEST STRIPS WHEN UNABLE TO RESOLVE THE ALLEGED ISSUE. THE PATIENT'S PAST BLOOD GLUCOSE RESULTS WERE NOT KNOWN. THE PATIENT SELF ADJUSTS HER INSULIN. BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER BEING UNABLE TO OBTAIN A BLOOD GLUCOSE RESULT, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2768371

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening