BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1911120 · Received November 30, 2010

    Report

    Report Number
    2939301-2010-10371
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 12, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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; 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6), 2010, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA2 METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6), 2010 AT 8AM. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. ABOUT 4-5 HOURS PRIOR TO THE START OF THE ALLEGED ISSUE, THE REPORTER CLAIMED THE PATIENT FELT A SYMPTOM OF FREQUENT URINATION. AT 1PM THAT DAY, THE PATIENT WAS TAKEN TO URGENT CARE AND WAS TREATED WITH INSULIN (6 UNITS REGULAR AND 20 UNITS NPH). THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "356 MG/DL" WITH THE HOSPITAL METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER. THE REPORTER WAS ADVISED THE BATTERIES NEED TO BE REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3046348

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening| R