BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1884310 · Received October 27, 2010

    Report

    Report Number
    2939301-2010-09537
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    October 9, 2010
    Report Date
    October 26, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA 2 METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6), 2010 AT 2:00 AM THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 170 MG/DL ON THE REPORTED METER, WHICH HE CLAIMED WAS INACCURATELY HIGH. THE PATIENT TOOK AN INSULIN DOSE, TYPE AND DOSE NOT PROVIDED, BASED ON THIS ELEVATED METER READING. AT 2:30 AM THE PATIENT EXPERIENCED THE SYMPTOMS OF HEADACHE AND HE "FELT SICK". THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING FOOD AND/OR A DRINK. EMERGENCY SERVICES WERE CONTACTED. AT 3:00 AM THE PARAMEDICS TESTED THE PATIENT'S BLOOD GLUCOSE READING TO BE 40 MG/DL. THE PATIENT MANAGES HIS DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER HE TOOK INSULIN BASED ON AN ELEVATED METER READING, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WITH FOOD. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R