BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1955349 · Received January 10, 2011

    Report

    Report Number
    2939301-2011-00308
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 11, 2010
    Report Date
    December 22, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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), 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY CONTROL LOW. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE CONTROL LOW READINGS OF "88 AND 83 MG/DL" WITH THE SUBJECT METER THAT BEGAN ON THE MORNING OF (B)(6), 2010. THE PATIENT INDICATED SHE MANAGES HER DIABETES WITH PILLS AND DIET/EXERCISE. DUE TO THE ALLEGED ISSUE, THE PATIENT DID NOT TAKE ANY ACTION REGARDING HER DIABETES MANAGEMENT REGIMEN. THE PATIENT CLAIMED A WEEK AFTER THE ALLEGED ISSUE BEGAN, SHE DEVELOPED SYMPTOMS OF DRY MOUTH AND FREQUENT URINATION. IN SPITE OF HER SYMPTOMS, THE PATIENT STATED DID NOT SEEK ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY THE SUBJECT METER'S UNIT OF MEASURE WAS CORRECT, THE CORRECT TEST STRIPS AND CONTROL SOLUTION WERE USED, AS WELL AS THE PATIENT'S PROCESS FOR TESTING WAS CORRECT. THE PATIENT WAS ABLE TO PERFORM A QUALITY CONTROL TEST, BUT THE RESULT DID NOT FALL WITHIN THE SPECIFIED CONTROL RANGE ON THE VIAL OF TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY BECAME HYPERGLYCEMIC A WEEK 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. 3062278

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening