BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA TEST STRIPS

    MDR report key: 2518596 · Received April 5, 2012

    Report

    Report Number
    2939301-2012-03383
    Event Type
    Injury
    Date Received
    April 5, 2012
    Date of Event
    March 14, 2012
    Report Date
    March 14, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 K043197.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA BLUE TEST STRIPS WERE DAMAGED. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN THE SECOND WEEKEND OF (B)(6) 2012. THE PATIENT MANAGES HER DIABETES WITH AN INSULIN PUMP (TYPE NOT SPECIFIED). IS IT NOT KNOWN IF CHANGES WERE MADE TO THE PATIENT'S USUAL DIABETES MANAGEMENT ROUTINE. A FEW HOURS AFTER THE ALLEGED ISSUE, THE PATIENT CLAIMS SHE FELT NERVOUS. THE PATIENT WAS UNABLE TO CONTINUE TESTING. ON THE MORNING OF (B)(6) 2012, SEVERAL DAYS AFTER THE ALLEGED ISSUE, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "380 MG/DL" WITH ANOTHER DEVICE. A HOME HEALTH NURSE ADMINISTERED THE PATIENT INSULIN (TYPE/ AMOUNT NOT SPECIFIED) AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT NO LONGER HAD THE LFS PRODUCTS AVAILABLE. 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 TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R