BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 920670 · Received September 28, 2007

    Report

    Report Number
    2939301-2007-01147
    Event Type
    Injury
    Date Received
    September 28, 2007
    Date of Event
    August 30, 2007
    Report Date
    August 31, 2007
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2007, THE LAY-USER/PATIENT CONTACTED LIFESCAN ALLEGING THE ONE TOUCH ULTRA METER IS GIVING INACCURATE HIGH READINGS. THE COMPLAINT IS BEING CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE (CCA). ACCORDING TO THE PT, THE METER STARTED TO GIVE INACCURATE HIGH READINGS. SIX WEEKS LATER, THE PT ALLEGEDLY REC'D INACCURATE READINGS OF "152, 149, AND 99 MG/DL" WHILE HAVING SYMPTOMS DESCRIBED AS "DIZZINESS, SHAKING, AND LIGHT HEADED." THE PT ADMINISTERED SELF-TREATMENT BY CONSUMING FOOD/BEVERAGE. THE PT WAS NOT TESTED ON ANY OTHER METER. DURING TROUBLESHOOTING, THE CCA VERIFIED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT MG/DL, THE PT WAS USING THE CORRECT TESTING TECHNIQUE, AND THE REPORTED READING MATCH WITH THE METER'S MEMORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE METER HAD BEEN GIVING THE ALLEGED INACCURATE HIGH READINGS. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2630292

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening