BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1173428 · Received September 23, 2008

    Report

    Report Number
    2939301-2008-02361
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 15, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVALUATION, 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 SEPTEMBER 15, 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRAMINI METER IS GIVING INACCURATE HIGH READING AND THE CONTROL SOLUTION IS FAILING. ACCORDING TO THE PATIENT, APPROXIMATELY A WEEK OR TWO AGO, THE PATIENT WAS GETTING ELEVATED BLOOD GLUCOSE READING OF "189 MG/DL." AS A RESULT OF THE HIGH READING, THE PATIENT REPORTEDLY INCREASED HIS INSULIN TO 12 UNITS. SOMETIME AFTER THE REPORTED ISSUE BEGAN, THE PATIENT ALLEGEDLY HAD SYMPTOMS DESCRIBED AS "SWEATY" AND ADMINISTERED SELF-TREATMENT WITH ORAL GLUCOSE. THE PATIENT WAS NOT TESTED ON ANY OTHER DEVICE AT THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES MEDICATION REGIMEN AND TESTING FREQUENCY, AND THE EVENTS LEADING UP TO THE PATIENT'S MEDICAL INTERVENTION SUCH AS BLOOD GLUCOSE READINGS, DIABETES MEDICATION INTAKE, FOOD INTAKE AND PHYSICAL ACTIVITIES. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TESTING TECHNIQUE WAS CORRECT, THE PUNCTURE AREA WAS CLEANED APPROPRIATELY, AND THE REPORTED METER READINGS WERE CONFIRMED IN THE METER'S MEMORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED THAT HE HAD SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA AFTER HE TOOK INSULIN PER AN ELEVATED LFS METER READING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2853882

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R