BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1151407 · Received September 4, 2008

    Report

    Report Number
    2939301-2008-01999
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 27, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF THE LFS PRODUCT IS RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE LFS PRODUCT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON AUGUST 27, 2008, THE LAY-USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONE TOUCH ULTRA METER IS REVERTING INTO THE SETUP MODE. THE PT CLAIMED THAT THE REVERTING INTO THE SETUP MODE ISSUE FIRST OCCURRED TWO WEEKS PRIOR TO CONTACTING LFS. SOME TIME AFTER THE REPORTED ISSUE BEGAN, THE PT HAD SYMPTOMS DESCRIBED AS "TREMBLING." 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. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PT TESTING FREQUENCY, DIABETES MEDICATION REGIMEN, AND THE EVENTS THAT LEAD UP TO THE REPORTED SYMPTOMS SUCH AS LFS METER READINGS FOOD AND DIABETES MEDICATION INTAKE, AND PHYSICAL ACTIVITIES. DURING TROUBLESHOOTING, THE REPORTED ISSUE WAS RESOLVED WITH TRAINING. THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE BATTERY HAD BEEN REPLACED PRIOR TO THE ONSET OF THE REPORTED ISSUE AND THERE WAS NO METER TRAUMA. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED SHE HAD SYMPTOMS THAT WERE SUGGESTIVE OF 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 2848467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening