BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA SMART METER

    MDR report key: 1033899 · Received April 25, 2008

    Report

    Report Number
    2939301-2008-00622
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    February 1, 2008
    Report Date
    April 7, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE LAY USER/PT INITIALLY CALLED LIFESCAN (LFS) IN 2008 AND ALLEGED THAT OK BUTTON ON HER ONE TOUCH ULTRASMART METER DOES NOT RESPOND. THE LIFESCAN (LFS) MEDICAL AFFAIRS ATTEMPTED TO CONTACT THE PT TO OBTAIN THE ADD'L INFO. THE LFS RECEIVED A CALL BACK FROM THE PT ON TWO WEEKS LATER AND OBTAINED THE FOLLOWING INFO. ACCORDING TO THE PT, THE REPORTED ISSUE BEGAN EITHER EARLY 2008. SHE WAS NOT TESTING HER BLOOD SUGAR AFTER THE REPORTED ISSUE. SHE WAS TAKING HER REGULAR DIABETES MEDICATION, METFORMIN ONE TABLET THREE TIMES DAILY DURING THE ISSUE. SOMETIME IN THE FOLLOWING MONTH, SHE WAS FEELING SWEATINESS AND DIZZINESS. SHE MENTIONED THAT DIZZINESS AND SWEATINESS ARE NORMALLY SYMPTOMS OF HIGH BLOOD SUGAR FOR HER. SHE PRIMARILY DID NOT DO ANYTHING TO TREAT HER SYMPTOMS. SHE THEN, WENT TO SEE HER DOCTOR ON THE SAME DAY WHEN SHE HAD STARTED FEELING THOSE SYMPTOMS. SHE WAS TESTED ON THE DOCTOR'S METER AND REPORTED A BLOOD SUGAR RESULT OF 237 MG/DL AND WAS TREATED WITH SOME INSULIN. THE CUSTOMER SVC AGENT (CSA) WAS ABLE TO RESOLVE THE ISSUE BY TROUBLESHOOTING. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE PT MENTIONED ABOUT NOT TESTING HER BLOOD SUGAR DUE TO THE REPORTED ISSUE AND LATER, FELT SWEATINESS AND DIZZINESS AND WAS TREATED WITH INSULIN AT THE DOCTOR'S OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA SMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2799451

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R