BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1082188 · Received July 24, 2008

    Report

    Report Number
    2939301-2008-01498
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    July 19, 2008
    Report Date
    July 21, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCTS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF THE LFS PRODUCTS ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE LFS PRODUCTS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON JULY 21, 2008, THE LAY-USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA METER IS GIVING A BATTERY INDICATOR MESSAGE. THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. THE BATTERY INDICATOR MESSAGE APPEARED APPROXIMATELY 3 DAYS AGO. REPORTEDLY, THE PT FELT SHAKY AFTER THE REPORTED ISSUE BEGAN. THE PT DID NOT TAKE ANY ACTION IN REGARDS TO DIABETES TREATMENT AND DID NOT RECEIVE ANY MEDICAL INTERVENTION BECAUSE OF THE REPORTED ISSUE. IN ADDITION, THE PT DID NOT TEST ON ANY OTHER DEVICE AT THE TIME OF CONCERN. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE BATTERY WAS NOT REPLACED PER THE OWNER'S MANUAL AND THE METER IN QUESTION IS NOT A NEW METER (OUT OF THE BOX). THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT HAD SYMPTOM THAT CAN BE SUGGESTIVE WITH SEVERE HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2837531

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening