BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2433168 · Received January 31, 2012

    Report

    Report Number
    2939301-2012-01106
    Event Type
    Injury
    Date Received
    January 31, 2012
    Report Date
    January 12, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K#: K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAMINI METER WAS DISPLAYING ONLY THE DISPLAY TEST SCREEN AND WOULD NOT PROCEED WITH TESTING. THE (B)(6) WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON AN UNSPECIFIED DATE IN APPROXIMATELY (B)(6) 2011 THE PATIENT NOTED THE REPORTED METER WOULD DISPLAY ONLY THE "888" DISPLAY TEST SCREEN, AND WOULD NOT PROCEED TO THE TESTING MODE. THE PATIENT WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. DURING THIS TIME PERIOD, THE PATIENT TOOK HER USUAL DOSES OF LANTUS INSULIN 50 UNITS THREE TIMES PER DAY. ONE WEEK AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF HEADACHE, MOOD SWINGS, WEAKNESS, FREQUENT URINATION AND BLURRED VISION. THE PATIENT WENT TO THE EMERGENCY ROOM, WHERE HER BLOOD GLUCOSE LEVEL WAS TESTED TO BE 500 MG/DL. THE PATIENT WAS TREATED INTRAVENOUSLY WITH FLUIDS AND INSULIN. IT WAS NOT POSSIBLE TO TROUBLESHOOT THE REPORTED METER ISSUE, AS THE PATIENT HAD DISCARDED THE METER. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVELS DUE TO THE METER ISSUE, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WITH INSULIN. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R