BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1020928 · Received March 27, 2008

    Report

    Report Number
    2939301-2008-00414
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN, ON MARCH 8, 2008 REPORTING THAT THE ONE TOUCH ULTRA METER WAS GIVING INACCURATE ERRATIC READINGS. IN 2008, IN THE MORNING , THE PATIENT TESTED HIMSELF ON THE LFS METER AND OBTAINED RESULTS OF "173, 137 AND 148 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEEDS THE EXPECTED VALUE OF <=20% AND/OR <= 20 MG/DL. BASED ON THE HIGHEST READING OF 173 MG/DL OBTAINED ON THE METER, THE PATIENT TOOK 10 UNITS OF NOVOMIX 30. AFTER 2-3 HOURS, THE PATIENT DEVELOPED SHAKINESS AND SWEATING SUGGESTING OCCURRENCE OF HYPOGLYCEMIC EPISODE. THE PATIENT IMMEDIATELY RESPONDED TO THIS SITUATION BY EATING 4 BISCUITS AND 1 CHOCOLATE SQUARE AND IN-BETWEEN TESTED HIMSELF ON THE METER OBTAINING READING OF 57 MG/DL. THE PATIENT CLAIMED TO FEEL BETTER VERY QUICKLY. HE DENIED SEEKING ANY MEDICAL ATTENTION. THE PATIENT USUALLY TAKES 6-10 UNITS OF NOVOMIX 30 IN THE MORNING. HE TAKES 6 UNITS IF BLOOD SUGAR STAYS BELOW 140 MG/DL MARK AND INCREASES INSULIN INTAKE UP TO 10 UNITS IF BLOOD SUGAR LEVEL EXCEEDS 170 MG/DL VALUE. IN THE AFTERNOON, THE PATIENT TAKES 0-6 UNITS OF NOVOMIX 30. HE DOES NOT TAKE ANY INSULIN IF THE READING STAYS BELOW 100 MG/DL AND TAKES 6 UNITS IF BLOOD SUGAR LEVEL GETS ELEVATED BEYOND 140 MG/DL MARK. AT DINNERTIME, THE PATIENT TAKES 10-12 UNITS OF NOVOMIX. THE PATIENT ALSO MENTIONED, THAT THE SLIDING SCALE MIGHT GET ALTERED ACCORDING TO WHAT HE WAS GOING TO EAT. THE CUSTOMER CARE ADVOCATE (CCA) DETERMINED THAT THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE AND THE TEST STRIPS WERE WITHIN EXPIRATION DATING AND IN GOOD CONDITION. THE METER WAS PROGRAMMED FOR THE CORRECT UNIT OF MEASURE AND CALIBRATION CODE NUMBER. THE RESULTS WERE VERIFIED IN THE METER'S MEMORY. REPLACEMENT PRODUCTS WERE SENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FACT THAT THE PATIENT CLAIMED HE DEVELOPED THE SYMPTOMS SUGGESTIVE HYPOGLYCEMIA AFTER INCREASING HIS INSULIN INTAKE BASED ON THE METER READING. THE PATIENT CLAIMED TO FEEL BETTER AFTER SELF-TREATING WITH FOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2791966

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R