BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1000999 · Received February 19, 2008

    Report

    Report Number
    2939301-2008-00204
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 26, 2008
    Report Date
    January 29, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CALLED LIFESCAN (LFS) IN 2008, ALLEGING SHE WAS UNABLE TO CHANGE THE CODE ON HER ONE TOUCH ULTRA2 METER. THE MEDICAL AFFAIRS SPECIALIST MAILED A LETTER ON FEBRUARY 19, 2008, SINCE THE USER COULD NOT BE REACHED BY TELEPHONE FOR FURTHER CLARIFICATION; THEREFORE, THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED, THE METER ISSUE BEGAN IN 2008. AFTER THE REPORTED ISSUE, THE PATIENT REPORTED FEELING LIGHTHEADED AND EXPERIENCING BLURRY VISION. THE PATIENT DENIED RECEIVING MEDICAL ATTENTION OR TAKING ACTION FOLLOWING USE OF THE METER. THE ISSUE WAS RESOLVED WITH TROUBLESHOOTING WITH THE CCA. THE METER WAS REPLACED. THIS COMPLAINT IS REPORTED BECAUSE THE PATIENT ALLEGES SHE WAS UNABLE TO CHANGE THE CODE ON THE LFS PRODUCTS, AND AFTERWARD EXPERIENCED SYMPTOMS THAT CAN BE ASSOCIATED WITH ABNORMAL BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2721031

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening