BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1992230 · Received February 15, 2011

    Report

    Report Number
    2939301-2011-01381
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S DAUGHTER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER WAS DISPLAYING AN ERROR 2 MESSAGE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT'S DAUGHTER ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT APPROXIMATELY 10 OR 11PM. ACCORDING TO THE PATIENT'S DAUGHTER, ON THE MORNING OF (B)(6) 2011 (TIME NOT KNOWN), THE PATIENT WAS EXPERIENCING SYMPTOMS OF DIZZINESS, WEAKNESS, NUMBNESS, AND BLURRY VISION. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF-ADJUSTER); HOWEVER, IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT'S DAUGHTER DENIED THE PATIENT TOOK ANY ACTION. PER CSR'S NOTES ON (B)(6) 2011 AT APPROXIMATELY 1:30PM, THE PATIENT WENT TO THE EMERGENCY ROOM (ER). DURING THE PATIENT'S TIME IN THE ER, THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "620MG/DL" WITH A LABORATORY DEVICE AT 3:25PM, AN MRI TEST WAS PERFORMED, AND THE PATIENT WAS GIVEN IV FLUIDS AT APPROXIMATELY 5:12PM. DURING TROUBLESHOOTING, THE CSR NOTED THERE WAS NO MISUSE OF THE LFS PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S DAUGHTER CLAIMS THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE, REPORTEDLY OBTAINED A HIGH LABORATORY BLOOD GLUCOSE RESULT, AND WAS REPORTEDLY TREATED BY AN HCP FOR SEVER HYPERGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3054226

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R