BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2922853 · Received January 18, 2013

    Report

    Report Number
    3008382007-2013-01076
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 10, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER WAS DISPLAYING INACCURATE RESULTS WHEN COMPARED TO THE SAME METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED ON (B)(6) 2013 AT 11PM, SHE OBTAINED READINGS OF '500, 269, 132, 333 AND 129MG/DL' ON THE LFS METER. THE PATIENT REPORTED TAKING NO MEDICATIONS TO MANAGE HER DIABETES. IT IS UNCLEAR IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED 10-15 MINUTES AFTER THE ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF 'FEELS PALE, NAUSEA, SHAKY, SWEATY AND DIZZY.' THE PATIENT REPORTED ON (B)(6) 2013 BETWEEN 11:30-12:15PM, SHE HAD SOMETHING TO EAT OR DRINK IN RESPONSE TO HER SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS USING AN APPROVED SAMPLE SITE FOR TESTING. THE PATIENT WAS FOUND TO BE USING THE CORRECT TESTING STEPS AND HIS TEST STRIPS AND TEST STRIPS VIAL WERE IN GOOD CONDITION. WHEN A CONTROL SOLUTION WAS RUN, THE RESULT WAS WITHIN THE RECOMMENDED RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED SELF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28008 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3366889

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R