BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2537373 · Received April 16, 2012

    Report

    Report Number
    2939301-2012-03717
    Event Type
    Injury
    Date Received
    April 16, 2012
    Report Date
    April 13, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K#: K021819.

    Description of Event or Problem · 1

    ON (B)(6), 2012 THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRASMART METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON AN UNSPECIFIED DATE AT 7:45 PM THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 368 MG/DL ON THE REPORTED METER, WHICH HE CLAIMED WAS INACCURATELY HIGH COMPARED TO HIS EXPECTED VALUES. BASED ON THIS ELEVATED READING, THE PATIENT TOOK AN INCREASED DOSE OF INSULIN, 18 UNITS 'UMALOC' 50 MIX INSULIN. AT 8:15 PM THE PATIENT EXPERIENCED THE SYMPTOMS OF FEELING COLD, DIZZINESS AND SWEATING. THE PATIENT DID NOT REPORT SEEKING ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PATIENT'S TEST STRIPS WERE EXPIRED, WHICH CAN CAUSE INACCURATE READINGS. THE METER WAS REPLACED. THE PATIENT'S TESTING TECHNIQUE WAS INCORRECT BY USING EXPIRED TEST STRIPS. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON AN ELEVATED METER READING. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2874967

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening