BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1192405 · Received October 6, 2008

    Report

    Report Number
    2939301-2008-02547
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVAL, BUT HAS NOT YET REC'D THEM. IF THE LFS PRODUCT IS RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE LFS PRODUCT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE LAY-USER/PATIENT ALLEGING THAT THE ONETOUCH ULTRA2 METER IS GIVING CONTROL SOLUTION RESULTS THAT ARE FALLING ABOVE THE CONTROL SOLUTION RANGE OF "104-139 MG/DL." ON 10/02/08, THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PT TO CLARIFY INFO OBTAINED FROM THE INITIAL CALL. THE PATIENT TESTS HIS BLOOD GLUCOSE MORE THAN 4 TIMES PER DAY AND CONTROLS HIS DIABETES WITH LANTUS AND NOVOLOG INSULIN. THE PT TAKES A SET AMOUNT OF LANTUS PER DAY AND BASES HIS NOVOLOG INSULIN ON A SLIDING SCALE PER LFS METER READINGS. THE REPORTER CLAIMED THAT AFTER THE INACCURATE HIGH ISSUE FIRST OCCURRED TWO WEEKS AGO PRIOR TO CONTACTING LFS, THE PT HAD SYMPTOMS DESCRIBED AS "SWEATING, SHAKY, AND DIZZY" FIVE TIMES. PRIOR TO THE ALLEGED 5 HYPOGLYCEMIC EPISODES, THE PT WOULD OBTAIN BLOOD GLUCOSE READING OF "225 MG/DL TO 300 MG/DL." THE PT INCREASED HIS INSULIN FROM HIS NORMAL 15 UNITS OF NOVOLOG TO 35 UNITS OF NOVOLOG PER HIS SLIDING SCALE INSULIN AND CARBOHYDRATE INTAKE TO INSULIN RATIO. THE PT INDICATED THAT THE ALLEGED HYPOGLYCEMIC EPISODE FREQUENCY WAS UNUSUAL FOR HIM. DURING THE FIVE REPORTED HYPOGLYCEMIC EPISODES, THE PT ALLEGEDLY OBTAINED READINGS SUCH AS "50, 60, AND 80 MG/DL," WHICH ACCORDING TO THE TP CORRELATED WITH THE AFOREMENTIONED SYMPTOMS. THE PT ADMINISTERED SELF-TREATMENT WITH FOOD/BEVERAGES. THE REPORTED SYMPTOMS LASTED SOMETIMES MINUTES, OTHER TIMES 2 HRS. THE PT FELT AS THOUGH HIS BLOOD GLUCOSE READINGS OBTAINED ON THE SUBJECT METER AT THE TIME OF CONCERN MAY HAVE BEEN FALSELY ELEVATED. HENCE, THE DIABETES TREATMENT, WHICH WAS BASED ON THE LFS METER, REPORTEDLY CAUSED HIM TO GO HYPOGLYCEMIC. THE PT COULD NOT PROVIDE INFO IN REGARDS TO THE EVENT THAT LEAD UP TO THE REPORTED SYMPTOMS SUCH AS FOOD INTAKE AND PHYSICAL ACTIVITIES. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TEST STRIPS AND CONTROL SOLUTION ARE WITHIN THE DISCARD DATE AND IN GOOD CONDITION, THE CONTROL SOLUTION TEST WAS NOT WITHIN RANGE WHEN A CONTROL SOLUTION TEST WAS RUN, THE METER IS CODED CORRECTLY, AND THE CORRECT CONTROL SOLUTION WAS USED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMED THAT THE PT HAD SYMPTOMS THAT WERE SUGGESTIVE OF HYPOGLYCEMIA AFTER THE PT TOOK INSULIN PER THE LFS METER'S ELEVATED READINGS. REPLACEMENT PRODUCTS 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 2826406

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R