BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1060330 · Received June 13, 2008

    Report

    Report Number
    2939301-2008-01092
    Event Type
    Injury
    Date Received
    June 13, 2008
    Report Date
    June 4, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, 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, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT ONETOUCH ULTRAMINI IS GIVING ERROR 2 MESSAGES. PER THE OWNER'S MANUAL, EITHER A USED TEST STRIP OR A PROBLEM WITH THE METER COULD CAUSE ERROR 2. ON EIGHT DAYS LATER, THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PATIENT TO OBTAIN MORE INFORMATION. HOWEVER, THE PATIENT PROVIDED LIMITED INFORMATION. THE PATIENT TESTS TWICE PER DAY AND CONTROLS HER DIABETES THROUGH DIET AND EXERCISE. THE REPORTED ISSUE FIRST OCCURRED ON ORIGINAL DATE AT 1:30 PM (CST). ACCORDING TO THE PATIENT, SHE ALLEGEDLY GOT "REALLY UPSET AND STARTED SHAKING DUE TO ISSUE." THE PATIENT FELT SHE WAS "LOW" AT THE TIME OF CONCERN. SHE ATE A SLICE OF BREAD AND DRANK SODA. THE PATIENT REPORTEDLY FELT BETTER AFTER 20 MINUTES. THE PATIENT DID NOT RECEIVE ANY FURTHER MEDICAL INTERVENTION. THE PATIENT TESTED ON ANOTHER ONETOUCH ULTRA2 METER BUT REPORTEDLY OBTAINED THE SAME ERROR MESSAGE. IT WOULD HAVE BEEN HELPFUL TO KNOW THE EVENTS THAT LEAD UP TO THE ONSET OF HER REPORTED SYMPTOMS SUCH AS FOOD INTAKE AND PHYSICAL ACTIVITY. DURING TROUBLESHOOTING, THE REPORTED ISSUE WAS RESOLVED THROUGH TRAINING. THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE PATIENT WAS APPLYING THE BLOOD TO THE TEST STRIP BEFORE INSERTING IT INTO THE METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE REPORTED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2786099

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R