BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2120769 · Received June 10, 2011

    Report

    Report Number
    2939301-2011-04769
    Event Type
    Injury
    Date Received
    June 10, 2011
    Report Date
    June 2, 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

    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 K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA2 METER READ INACCURATELY WHEN COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 10AM. THE PATIENT REPORTED UNSPECIFIED RESULTS WITH THE SUBJECT METER AND "200 MG/DL" ON ANOTHER METER, PERFORMED GREATER THAN 30 MINUTES OF EACH OTHER. THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH METFORMIN PILLS AND GLYBURIDE PILLS. IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. SEVERAL DAYS AFTER THE ALLEGED ISSUE BEGUN, THE PATIENT CLAIMED HE FELT SYMPTOMS OF BLURRY VISION AND HAD PAIN IN HIS FOOT. ON (B)(6) 2011, THE PATIENT VISITED HIS PHYSICIAN'S OFFICE. THE PATIENT WAS REFERRED TO AN "EYE DOCTOR" AND ORDERED TO GET "X RAYS ON HIS FEET." THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "150 MG/DL" WITH THE PHYSICIAN'S METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE CCA WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST WHICH FELL WITHIN RANGE. 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3129428

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening