BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243789 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03209
    Event Type
    Injury
    Date Received
    November 24, 2008
    Report Date
    November 11, 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

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER STARTED TO DISPLAY THE BATTERY INDICATOR SYMBOL A MONTH PRIOR. IT IS UNKNOWN HOW OFTEN THE PATIENT USUALLY TESTS WITH HER METER AND IF SHE HAD A BACKUP METER TO USE. SHE REPORTEDLY SELF ADJUSTS HER INSULIN DOSAGE BUT HER SPECIFIC MEDICATION REGIMEN WAS NOT REPORTED. SHE CLAIMED THAT ONE WEEK AFTER THE ISSUE FIRST OCCURRED, SHE DEVELOPED SYMPTOMS OF DIZZINESS, SLEEPINESS, FATIGUE, AND BLURRY VISION. ON AN UNSPECIFIED DATE, SHE ATTEMPTED TO GO TO HER DOCTOR'S OFFICE BUT THE OFFICE WAS CLOSED. THE PATIENT ALSO STATED THAT SHE WAS HAVING LESS FOOD/DRINK A "COUPLE OF WEEKS AGO" AS A RESULT OF THE METER ISSUE. IT IS UNCLEAR IF SHE STARTED TO HAVE LESS FOOD/DRINK BEFORE OR AFTER SHE ATTEMPTED TO SEE HER DOCTOR. NO OTHER FORMS OF TREATMENT OR BLOOD GLUCOSE RESULTS FROM THE OTHER DEVICES WERE REPORTED. THE CUSTOMER CARE ADVOCATE (CCA) WALKED THE PATIENT THROUGH TROUBLESHOOTING AND NOTED THAT THE BATTERY WAS NOT REPLACED PER THE OWNER'S MANUAL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE WAS NO INDICATION THAT THE LFS PRODUCT MALFUNCTIONED SINCE THE BATTERY WAS NOT REPLACED PER THE OWNER'S MANUAL. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS, SUGGESTIVE OF A SERIOUS INJURY ONE WEEK AFTER THE BATTERY INDICATOR APPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 3857934

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening