BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1880742 · Received October 25, 2010

    Report

    Report Number
    2939301-2010-09325
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 15, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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'S SON CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA2 METER WAS TESTING IN THE SETTINGS MODE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE PATIENT AND THE SON ON (B)(6), 2010 FOR FOLLOW UP CLINICAL QUESTIONS, HOWEVER BOTH WERE UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S SON REPORTED THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6), 2010 AT 7:00AM. IT IS NOT SPECIFIED IN THE DOCUMENTATION IF THE PATIENT WAS TAKING ANY DIABETES MEDICATIONS OR IF ANY CHANGES WERE MADE REGARDING HER DIABETES MANAGEMENT ROUTINE AT THE TIME OF THE ALLEGED ISSUE. THE SON STATED THAT THE PATIENT WAS EXPERIENCING CONSTANT URINATION AFTER THE ALLEGED ISSUE BEGAN; HOWEVER IT IS UNKNOWN IN THE DOCUMENTATION HOW MUCH TIME PASSED BETWEEN THE START OF THE ALLEGED ISSUE AND THE START OF HER SYMPTOM. IN RESPONSE TO THE SYMPTOM, THE SON STATED THAT THE PATIENT DID NOT RECEIVE ANY MEDICAL TREATMENT AFTER THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CCA EDUCATED THE SON ON THE CORRECT TESTING PROCEDURE WITH THE SUBJECT METER. THE ALLEGED ISSUE WAS RESOLVED WITH TRAINING. 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. 3032134

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening