BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1080446 · Received July 21, 2008

    Report

    Report Number
    2939301-2008-01448
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    July 5, 2008
    Report Date
    July 9, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    ON JULY 9, 2008, THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE LAY-USER/PATIENT ALLEGING THAT THE ONETOUCH ULTRA2 METER IS GIVING AN ERROR MESSAGE THAT THE PATIENT DOES NOT RECALL THE EXACT NUMBER. THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. ON THE MORNING OF THREE DAYS PRIOR, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS DESCRIBED AS "JITTERY" WHILE THE REPORTED ISSUE (UNKNOWN ERROR MESSAGE) FIRST OCCURRED. THE PATIENT DID NOT TAKE ANY ACTIONS IN REGARDS TO DIABETES TREATMENT AS A RESULT OF THE REPORTED ISSUE. AT NOONTIME, THE PATIENT REPORTEDLY RECEIVED ASSISTANCE FROM A HEALTHCARE PROVIDER AND WAS REPORTEDLY GIVEN FOOD/BEVERAGES. THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE OF "123 MG/DL" ON DOCTOR'S/CLINIC'S METER AT THE TIME OF CONCERN. IT IS NOT KNOWN WHEN THE "123 MG/DL" WAS OBTAINED IN RELATION TO THE FOOD/BEVERAGE INTERVENTION. IT WOULD HAVE BEEN HELPFUL TO OBTAIN THE FOLLOWING INFORMATION: WHAT TIME ON THE SAME DAY, DID THE PATIENT START TO FEEL "JITTERY," WHY THE PATIENT SOUGHT MEDICAL ASSISTANCE ON THE SAME DAY, AND WAS TREATED WITH FOOD/BEVERAGE, WHAT BLOOD GLUCOSE READING THE PATIENT OBTAINED PRIOR THE MEDICAL TREATMENT WITH FOOD/BEVERAGE, AND WHAT WAS THE PATIENT'S DIAGNOSE AT THE CLINIC/DOCTOR'S OFFICE. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THERE IS NO METER TRAUMA AND THE REPORTED ISSUE WAS NOT RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT RECEIVED MEDICAL INTERVENTION THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Life Threatening| R