BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1032818 · Received April 21, 2008

    Report

    Report Number
    2939301-2008-00608
    Event Type
    Injury
    Date Received
    April 21, 2008
    Report Date
    April 5, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCT FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE PRODUCTS IS 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/REPORTER CALLED LIFESCAN (LFS) ON BEHALF OF THE LAY USER/PATIENT IN 2008, AND ALLEGED THAT SOMETIMES HER ONE TOUCH ULTRA METER DOES NOT POWER ON. THE MEDICAL AFFAIRS SPECIALIST IS CLASSIFYING THE COMPLAINT BASED ON AVAILABLE INFORMATION, AS THE REPORTER COULD NOT BE CONTACTED BY PHONE TO OBTAIN ADDITIONAL INFORMATION. ACCORDING TO THE PATIENT'S DAUGHTER, THE REPORTED ISSUE STARTED THE FOLLOWING DAY, AT AROUND 9:30 AM. THE PATIENT WAS FEELING SHAKY SOMETIME AFTER THE ISSUE. SHE TREATED HERSELF BY EATING OR DRINKING SOMETHING. SHE WAS NOT TESTED ON ANOTHER DEVICE AT THE TIME OF CONCERN. IT IS UNKNOWN WHETHER THE PATIENT WAS ABLE TO TEST HER BLOOD SUGAR DURING OR PRIOR TO FEELING SHAKINESS OR NOT. THE CUSTOMER SERVICE AGENT (CSA) VERIFIED THAT THE PATIENT WAS USING CORRECT TEST STRIPS, THE METER WAS NOT DOWNLOADED RECENTLY AND NO TRAUMA OCCURRED TO THE METER. THE METER WAS POWERING ON DURING TROUBLESHOOTING BY PRESSING THE POWER BUTTON AND ALSO BY INSERTING THE TEST STRIP INTO THE TEST STRIP PORT. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE REPORTER CLAIMED OF THE PATIENT, SOMETIMES NOT BEING ABLE TO TEST HER BLOOD SUGAR DUE TO THE REPORTED ISSUE AND LATER, FELT SHAKINESS, WHICH CAN BE A CHARACTERISTIC SYMPTOM ASSOCIATED WITH SEVERE HYPOGLYCEMIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R