BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2032064 · Received March 28, 2011

    Report

    Report Number
    2939301-2011-02653
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2011. THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH GLUCOPHAGE PILLS, LANTUS INSULIN AND HUMALOG INSULIN. IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING SYMPTOMS. ON (B)(6) 2011 AT 10AM, THE PATIENT VISITED HIS PHYSICIAN'S OFFICE AND OBTAINED A BLOOD GLUCOSE RESULT OF "250 MG/DL" ON ANOTHER DEVICE. THE PATIENT WAS ADMINISTERED 20 UNITS HUMALOG INSULIN AS TREATMENT. 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. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2841931

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R