BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA 2 METER

    MDR report key: 1242248 · Received November 19, 2008

    Report

    Report Number
    2939301-2008-03180
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 7, 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
    FL, 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/REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE LAY-USER/PATIENT ALLEGING THAT THE ONE TOUCH ULTRA2 METER IS GIVING INACCURATE HIGH READINGS. ON NOVEMBER 3, 2008, THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PATIENT WITH FOLLOW-UP QUESTIONS. HOWEVER, THE PATIENT WAS NOT ABLE TO PROVIDE MORE INFORMATION ABOUT THE INCIDENT THE FIRST WEEK ON THE ORIGINAL MONTH. THE PATIENT TESTS MORE THAN 4 TIMES PER DAY AND CONTROLS HER DIABETES WITH 70/30 MIX INSULIN (10 UNITS PER DAY) AND HUMALOG INSULIN. THE HUMALOG INSULIN IS TAKEN BASED ON A SLIDING SCALE PER THE LFS METER READINGS. THE PATIENT IS REPORTEDLY DIAGNOSED WITH ALZHEIMER'S DISEASE. ACCORDING TO THE REPORTER, THE INACCURATE HIGH ISSUE FIRST OCCURRED IN APPROX SIX MONTHS PRIOR. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "168 MG/DL" WITH A LIFESCAN METER AND "68 OR 69 MG/DL" ON A LABORATORY DEVICE, PERFORMED WITHIN 10-30 MINUTES OF EACH OTHER. BETWEEN THE TESTS THERE WAS NO INTERVENTION THAT WOULD BE EXPECTED TO CHANGE THE BLOOD GLUCOSE. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. ON EARLY OF THE ORIGINAL MONTH AT 8:30 A.M., THE PATIENT RECEIVED MEDICAL INTERVENTION AT THE HOSPITAL. IT IS NOT KNOWN WHY THE PATIENT WENT TO THE HOSPITAL THAT DAY. THE PATIENT WAS ADMITTED INTO THE HOSPITAL WHERE SHE OBTAINED A BLOOD GLUCOSE READING OF "40 MG/DL" ON A LAB. THE REPORTER CLAIMED THAT THE PATIENT WAS "GIVEN A SHOT OF SOMETHING". THE PATIENT DID NOT HAVE ANY SYMPTOMS BEFORE, DURING, OR AFTER THE INACCURATE HIGH ISSUE BEGAN. THE PATIENT WAS GIVEN ALZHEIMER'S MEDICATION AFTER HER RELEASE FROM THE HOSPITAL THAT DAY. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES MEDICATION REGIMEN AND TESTING FREQUENCY, AND THE EVENTS LEADING UP TO THE PATIENT'S MEDICAL INTERVENTION SUCH AS BLOOD GLUCOSE READINGS, DIABETES MEDICATION INTAKE, FOOD INTAKE, AND PHYSICAL ACTIVITIES. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TESTING TECHNIQUE WAS CORRECT, THE PUNCTURE AREA WAS CLEANED APPROPRIATELY, THE METER WAS CODED CORRECTLY, AND THE REPORTED METER READINGS WERE CONFIRMED IN THE METER'S MEMORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMED THAT THE PATIENT SUFFERED A SERIOUS INJURY AFTER THE REPORTED ISSUE BEGAN. THE PATIENT'S LOW BLOOD GLUCOSE READING OBTAINED ON THE LAB SUGGESTED THAT THE PATIENT HAD A SEVERE HYPOGLYCEMIC EPISODE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA 2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R