BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3935809 · Received July 15, 2014

    Report

    Report Number
    2939301-2014-17448
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 28, 2014
    Report Date
    June 30, 2014
    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
    NY, US
    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. PT AGE, GENDER, WEIGHT: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6), 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONETOUCH ULTRA2 METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6), 2014 AT 8:00 AM THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 502 MG/DL ON THE REPORTED METER. AT 8:05 AM THE PATIENT TOOK AN INCREASED DOSE OF 30.0 UNITS HUMALOG INSULIN. AT 9:30 AM THE PATIENT EXPERIENCED THE SYMPTOMS OF SWEATING, BLURRED VISION, DISORIENTATION AND SHE FELT FAINT. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING ORANGE JUICE. AT 10:00 AM THE PATIENT TESTED HER BLOOD GLUCOSE LEVEL WITH A ONETOUCH VERIO METER AND OBTAINED THE READING OF 32 MG/DL. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON AN ELEVATED METER READING, AND RECEIVED TREATMENT WITH FOOD. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412143 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3447403

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R