BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1060363 · Received June 17, 2008

    Report

    Report Number
    2939301-2008-01061
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PATIENT'S DAUGHTER CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONE TOUCH ULTRA METER WAS DISPLAYING AN "ER5." PER THE ONE TOUCH ULTRA OWNER'S BOOKLET, AN "ER5" MESSAGE INDICATES THAT THE METER DETECTED A PROBLEM WITH THE TEST STRIP. POSSIBLE CAUSES ARE TEST STRIP DAMAGE OR AN INCOMPLETELY FILLED CONFIRMATION WINDOW. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO REACH THE PATIENT BY PHONE. THE PATIENT'S DAUGHTER REPORTED THAT THE ALLEGED ISSUE OCCURRED THE MORNING OF CONTACTING LFS. ON THE SAME DAY AT 6:30AM, THE PATIENT ATTEMPTED TO TEST HIS GLUCOSE AND OBTAINED THE MESSAGE OF "ER5" INSTEAD OF A READING. AS A RESULT OF THE REPORTED ISSUE, IT WAS REPORTED THAT THE PATIENT ONLY TOOK ONE OF HIS TWO ORAL MEDICATIONS. THE PATIENT SKIPPED HIS DOSE OF GLIPIZIDE (10MG). SOMETIME THAT SAME MORNING, AFTER THE REPORTED ISSUE BEGAN, THE PATIENT REPORTED FEELING "SWEATY AND DIZZY." IT IS UNCLEAR WHAT ACTIONS THE PATIENT TOOK, IF ANY, TO RELIEVE THESE SYMPTOMS. AT 9:30AM, THE PATIENT'S DAUGHTER MENTIONED THEY TOOK THE METER TO THEIR LOCAL PHARMACY TO OBTAIN ASSISTANCE WITH THE ERROR MESSAGE. THE PHARMACIST ADVISED THE PT TO CONTACT LFS, SINCE THEY WERE UNABLE TO RESOLVE THE ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE AND THAT THE TEST STRIPS WERE IN GOOD CONDITION. THE REPORTED ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS, HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE NBW LIFESCAN, INC. NA 2813561

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening