BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3230732 · Received July 17, 2013

    Report

    Report Number
    3008382007-2013-19946
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 24, 2013
    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
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER WAS DISPLAYING INACCURATELY HIGH READINGS COMPARED TO HER FEELINGS OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED PRIOR TO THE START OF THE ALLEGED ISSUE SHE FELT ¿DIZZY, SICK AND WEAK.¿ IT IS UNCLEAR IF SHE ASSOCIATES THESE SYMPTOMS WITH HIGH OR LOW BLOOD GLUCOSE. THE PATIENT REPORTED ON (B)(6) 2013 IN THE MORNING SHE OBTAINED A MESSAGE OF ¿HI¿ ON THE LFS METER. THE PATIENT REPORTED USING ORAL MEDICATIONS INCLUDE JANUMET (UNKNOWN DOSE) TO MANAGE HER DIABETES. THE PATIENT REPORTED ON (B)(6) 2013 IN THE MORNING, WHILE SHE WAS IN THE EMERGENCY ROOM (ER) HER MEDICATIONS WERE CHANGED FROM JANUMET TO 1000 MG METFORMIN. THE PATIENT REPORTED ON (B)(6) 2013 IN THE MORNING, A BLOOD GLUCOSE READING OF ¿303MG/DL¿ WAS OBTAINED AND THE PATIENT WAS GIVEN IV FLUIDS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND THE TEST STRIPS WERE IN GOOD CONDITION. HOWEVER A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING ANY CONTROL SOLUTION AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE, THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE SHE REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL IN THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331583 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3445345

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R