BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1081606 · Received July 25, 2008

    Report

    Report Number
    2939301-2008-01521
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 11, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, 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

    IN 2008, A REPORTER/LAYPERSON ALLEGED TO A CUSTOMER CARE ADVOCATE, CCA, THAT HER HUSBAND'S (PT/LAYPERSON) RESULTS WERE ERRATIC WHEN TESTING ON HIS ONE TOUCH ULTRA 2. REPORTEDLY, AT 9:00 AM ON THE SAME DAY, A FEW HOURS PRIOR TO CALLING, THE PT OBTAINED 199, 156, AND 159 MG/DL. RESULTS WERE MORE THAN 20 MINUTES APART. AFTER THE ISSUE BEGAN, THE PT ALLEGEDLY WAS SHAKY. HE ATE AND/OR DRANK A BEVERAGE. A CONTROL TEST PERFORMED FOR THE CCA WAS ABOVE THE SPECIFIED RANGE. NO MEDICAL INTERVENTION WAS REQUIRED. THE COMPLAINT IS CLASSIFIED BASED UPON THE INFO GIVEN TO THE CCA. THE CCA REPLACED PRODUCTS. BECAUSE THE PT REPORTEDLY EXPERIENCED A SYMPTOM THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE ISSUE BEGAN, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2791272

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening