BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1912055 · Received December 1, 2010

    Report

    Report Number
    2939301-2010-10399
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 15, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/REPORTER CONTACTED LIFESCAN TO REPORT AN ISSUE WITH THE SETTINGS ON THE ONE TOUCH ULTRA 2 METER. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6) 2010, THE PATIENT NOTED SHE WAS UNABLE TO USE THE REPORTED METER TO TEST HER BLOOD GLUCOSE LEVELS, AS THE METER WAS BRAND NEW AND NOT YET SET UP. THE PATIENT TOOK NO ACTIONS DUE TO THE METER ISSUE. AFTER THE USE OF THE METER, THE PATIENT EXPERIENCED THE SYMPTOM OF SHAKING. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE PATIENT HAD RECENTLY BEEN DISCHARGED FROM THE HOSPITAL, AND THIS NEW METER HAD NOT YET BEEN SET UP. THE PATIENT MANAGES HER DIABETES WITH ORAL DIABETES MEDICATION. TROUBLESHOOTING REVEALED THIS WAS A NEW, OUT-OF-THE-BOX, METER AND HAD NOT YET BEEN PROGRAMMED WITH THE CORRECT CALIBRATION CODE NUMBER OR DATE AND TIME. THE ISSUE WAS RESOLVED WITH PATIENT EDUCATION. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT HAD NOT YET SET UP THE NEW METER WITH THE CORRECT CALIBRATION CODE NUMBER AND DATE/TIME. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVEL DUE TO THE METER ISSUE. 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. 2998230

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening