BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1081639 · Received July 22, 2008

    Report

    Report Number
    2939301-2008-01463
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    July 13, 2008
    Report Date
    July 13, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 IT. IF THE LFS PRODUCT IS RETURNED, LIFESCAN WILL EVALUATE IT 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 JULY 13, 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT ONE TOUCH ULTRASMART METER IS GIVING AN APPLY SAMPLE MESSAGE. THE PATIENT TESTS HIS BLOOD GLUCOSE TWICE PER DAY AND CONTROLS HIS DIABETES WITH PILLS, DIET AND EXERCISE. THE PATIENT INDICATED THAT THE REPORTED ISSUE BEGAN APPROXIMATELY DURING 2007. THE PATIENT DID NOT TAKE ANY ACTION IN REGARDS TO DIABETES TREATMENT AS A RESULT OF THE REPORTED ISSUE. SOMETIME AFTER THE REPORTED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS DESCRIBED AS "TIRED, LIGHT-HEADED AND GOING TO THE RESTROOM A LOT." ON EIGHT DAYS PRIOR TO ORIGINAL DATE, THE PATIENT SOUGHT MEDICAL ADVICE/ASSISTANCE FROM HEALTHCARE PROVIDER. THE PATIENT OBTAINED A BLOOD GLUCOSE READING IN THE "200 MG/DL" RANGE AND WAS ADVISED TO TAKE 500 MG OF METFORMIN TWICE PER DAY. IT WOULD HAVE BEEN HELPFUL TO KNOW IF THE PATIENT WAS ABLE TO TEST HIS BLOOD GLUCOSE AFTER THE REPORTED ISSUE BEGAN, IF THE REPORTED SYMPTOMS OF "TIRED, LIGHTHEADED AND GOING TO THE RESTROOM A LOT" ARE SYMPTOMS THE PATIENT HAS FROM TIME TO TIME OR ARE THE REPORTED SYMPTOMS AS A RESULT OF THE REPORTED ISSUE OF "APPLY SAMPLE," THE TIME AND DATE OF WHEN THE REPORTED SYMPTOMS BEGAN, WHAT IF ANY LFS METER READINGS THE PATIENT OBTAINED PRIOR TO AND DURING THE REPORTED SYMPTOMS, AND IF THE PATIENT FELT BETTER AFTER THE MEDICAL INTERVENTION. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE CORRECTED THE PATIENT'S TESTING TECHNIQUE AND THE REPORTED ISSUE WAS RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD SYMPTOMS THAT COULD BE SUGGESTIVE OF HYPERGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2721304

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R