BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2038431 · Received April 4, 2011

    Report

    Report Number
    2939301-2011-02810
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 25, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 5PM. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH NOVOLOG 70/30 INSULIN (25 UNITS), METFORMIN PILLS (500 MG) AND GLIPIZIDE PILLS (10 MG). IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. ABOUT 4 ½ HOURS AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE FELT SHAKY. THE PATIENT TOOK FOOD AND/ OR DRANK A BEVERAGE AS TREATMENT. ON THE MORNING OF (B)(6) 2011, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "205 MG/DL" WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER. THE CCA WALKED THE PATIENT THROUGH RESOLVING THE ALLEGED ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3051501

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R