BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1033896 · Received April 25, 2008

    Report

    Report Number
    2939301-2008-00620
    Event Type
    Injury
    Date Received
    April 25, 2008
    Report Date
    April 5, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 CALLED LIFESCAN (LFS) IN 2008 AND ALLEGED THAT HER ONE TOUCH ULTRA 2 METER WAS POWERING OFF DURING USE. THE MEDICAL AFFAIRS SPECIALIST IS CLASSIFYING THE COMPLAINT BASED ON AVAILABLE INFO, AS THE PT COULD NOT BE CONTACTED BY PHONE TO OBTAIN ADD'L INFO. ACCORDING TO THE PT, THE REPORTED ISSUE STARTED AT THE END OF THE PREVIOUS MONTH IN THE MORNING. SHE REPORTED OF SWEATING A LOT AND FEELING THIRSTY SOMETIME AFTER THE REPORTED ISSUE. SHE ALSO MENTIONED ABOUT RECEIVING ASSISTANCE FROM A HEALTH CARE PRACTITIONER (HCP) ON FOUR DAYS PRIOR TO ORIGINAL DATE IN THE MORNING. SHE WAS TESTED FOR HER BLOOD SUGAR AT THE DOCTOR'S OFFICE AND RECEIVED A BLOOD SUGAR READING OF 198 MG/DL. SHE WAS ADVISED BY HER DOCTOR TO INCREASE HER DIABETES MEDICATION DOSAGE. SHE MENTIONED ABOUT TAKING GLUCOPHAGE TABLETS THREE TIMES DAILY. THE CUSTOMER SVC AGENT (CSA) VERIFIED THAT THE PT HAS RECENTLY REPLACED THE BATTERY IN THE METER, THE METER WAS NOT DOWNLOADED RECENTLY, THE CONDITION OF THE BATTERY CONTACTS WAS GOOD, AND THERE WAS NO TRAUMA OCCURRED TO THE METER. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE PT REPORTED OF THE LFS METER POWERING OFF DURING USE AND LATER, FELT THIRSTY, WHICH CAN BE ASSOCIATED WITH HYPERGLYCEMIA. SHE ALSO REPORTED OF FEELING SWEATINESS, A SYMPTOM THAT CAN BE A CHARACTERISTIC SYMPTOM OF SEVERE HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2682043

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R