BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1242243 · Received November 19, 2008

    Report

    Report Number
    2939301-2008-03186
    Event Type
    Injury
    Date Received
    November 19, 2008
    Report Date
    November 5, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED THE 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

    IN 2008, THE PATIENT/LAYPERSON ALLEGED THAT SHE WAS UNABLE TO CODE HER ONETOUCH ULTRA METER DUE TO A BATTERY DISPLAY ISSUE. THE PATIENT CONTINUED TO TAKE HER USUAL ORAL MEDS, METFORMIN, JENUVIA, AND GLYPIZIDE. ALLEGEDLY, THREE DAYS AFTER THE REPORTED ISSUE BEGAN, THE PATIENT WAS SHAKY, LIGHTHEADED AND DIZZY. THE PATIENT'S BLOOD GLUCOSE READINGS PRIOR TO THIS EVENT WERE NOT KNOWN. THE PATIENT DID NOT RECEIVE MEDICAL INTERVENTION. UNABLE TO RESOLVE THE ALLEGED ISSUE, CUSTOMER SERVICE REPLACED THE METER. UNABLE TO SPEAK WITH THE PATIENT, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT BASED UPON THE ALLEGATION THAT THE PATIENT HAD SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2567892

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening