BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1222087 · Received November 4, 2008

    Report

    Report Number
    2939301-2008-02932
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 18, 2008
    Report Date
    October 23, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    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 EVALUATION, BUT HAS NOT YET RECEIVED 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/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH UNTRA2 METER IS GIVING INACCURATE HIGH READINGS COMPARED TO FEELINGS/NORMAL READINGS. THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE AND THE ANSWERS TO THE FOLLOW-UP QUESTIONS THIS MEDICAL AFFAIRS SPECIALIST OBTAINED ON OCTOBER 31, 2008. THE PATIENT TESTS HIS BLOOD GLUCOSE 3 TIMES PER DAY AND CONTROLS HIS DIABETES WITH 70/30 MIXED INSULIN AND ORAL DIABETES MEDICATION (ACTOS AND GLYBURIDE). THE PATIENT TAKES HIS INSULIN BASED ON A SLIDING SCALE PER THE LFS METER READINGS. ACCORDING TO THE PATIENT, THE INACCURATE HIGH ISSUE FIRST OCCURRED ON FIVE DAYS PRIOR TO ORIGINAL DATE AT 7:05AM. THE PATIENT OBTAINED READINGS SUCH AS "95, 141, AND 162 MG/DL" ON THE SUBJECT METER. SOMETIME AFTER THE INACCURATE HIGH ISSUE BEGAN, THE PATIENT REPORTEDLY HAD SYMPTOMS DESCRIBED AS "SHAKES." THE PATIENT REPORTEDLY HAD TWO EPISODES OF HYPOGLYCEMIA AFER THAT DAY. BASED ON AN ELEVATED BLOOD GLUCOSE READING OF "210 MG/DL" OBTAINED ON THE SUBJECT METER AT AN UNSPECIFIED DATE AND TIME, THE PATIENT ALLEGEDLY TOO 10 UNITS OF 70/30 MIX INSULIN AND HAD A LITTLE SNACK. WITHIN ONE HOUR, THE PATIENT REPORTEDLY HAD SYMPTOMS OF FEELING SHAKY. THEN THE PATIENT OBTAINED A READING OF "55 OR 60 MG/DL" ON THE SUBJECT METER AND PROMPTLY ADMINISTERED SELF-TREATMENT WITH FOOD/BEVERAGES. THE DURATION OF THE SYMPTOMS LASTED NO LONGER THAN 2 HOURS. THE PATIENT DID NOT TEST ON ANY OTHER DEVICE AT THE TIME OF CONCERN. THE PATIENT FEELS THAT HAD THE SUBJECT METER GIVEN HIM ACCURATE READINGS, HE WOULD HAVE TREATED HIS DIABETES ACCORDINGLY AND PREVENTED THE REPORTED SYMPTOMS. THE PATIENT'S DIABETES MEDICATION REGIMEN AND TESTING FREQUENCY HAS BEEN CHANGED IMMEDIATELY BEFORE OR AFTER THE AFOREMENTIONED SYMPTOMS BEGAN. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TESTING TECHNIQUE WAS CORRECT, THE PUNCTURE AREA WAS CLEANED APPROPRIATELY, AND THE REPORTED METER READINGS WERE CONFIRMED IN THE METER'S MEMORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED THAT HE HAD SYMPTOMS THAT CAN BE SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER HE DOSED HIS INSULIN PER THE LFS METER READING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2723369

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening| R