BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1030031 · Received April 14, 2008

    Report

    Report Number
    2939301-2008-00551
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 26, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON MARCH 26, 2008, THE LAY-USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT ONE TOUCH ULTRA 2 METER IS HAVING CALCODE ISSUES (METER IS NOT CODED WITH THE CORRECT CALCODE). ON APRIL 7, 2008, THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PT VIA A LANGUAGE LINE SVC (SPANISH) TO OBTAIN MORE INFO. THE PT TESTS HER BLOOD GLUCOSE ONCE EVERY OTHER DAY AND TAKES AMARYL (DIABETES ORAL MEDICATION). AFTER THE REPORTED ISSUE FIRST OCCURRED IN 2008, THE PT COULD NOT TEST HIS BLOOD GLUCOSE. THE PT WAS TAKING HER USUAL DIABETES MEDICATION OF AMARYL (2 PILLS OF 4 MG) AFTER THE REPORTED ISSUE BEGAN. AT AN UNSPECIFIED DATE AND TIME, THE PT DEVELOPED SYMPTOMS OF "DIZZY AND VERY BLURRED VISION." IN ADDITION, EIGHT DAYS LATER, THE PT WENT INTO THE DR'S OFFICE FOR A ROUTINE VISIT. THE PT WAS TESTED ON A DR'S/CLINIC'S METER AT "300 MG/DL" AND WAS GIVEN INSULIN (UNSPECIFIED TYPE AND DOSE). THE PT INDICATED THAT AFTER THE DR'S VISIT, HER DIABETES MEDICATION REGIMEN WAS CHANGED. HOWEVER, THE PT WAS NOT ABLE TO PROVIDE THE DOSE AND TYPE OF DIABETES MEDICATION, AS SHE DOES NOT HAVE HER MEDICATION WITH HER AT THE TIME OF THE CALL. DURING TROUBLESHOOTING, THE REPORTED ISSUE WAS RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, BECAUSE THE PT CLAIMED, SHE EXPERIENCED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA AND WAS TREATED WITH INSULIN AFTER THE REPORTED ISSUE BEGAN. REPLACEMENT PRODS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2680502

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R