BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2495546 · Received March 19, 2012

    Report

    Report Number
    2939301-2012-02674
    Event Type
    Injury
    Date Received
    March 19, 2012
    Report Date
    February 28, 2012
    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

    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. THE 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS DISPLAYING THE "ERROR 1" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN 4 DAYS AGO PRIOR TO CONTACTING LFS. THE PATIENT CLAIMED SHE MANAGES HER DIABETES WITH INSULIN. DUE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE RESPONDED TO EXERCISING. A WEEK AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT REPORTED TO HAVE DEVELOPED SYMPTOMS OF NAUSEA, DIZZINESS, AND BLURRED VISION. THE PATIENT, HOWEVER, DENIED SEEKING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS NOT A 1ST TIME USER OF THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY 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. 3245973

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening