BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2060371 · Received April 15, 2011

    Report

    Report Number
    2939301-2011-03136
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    April 3, 2011
    Report Date
    April 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 K021819.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRASMART METER WAS DISPLAYING AN UNSPECIFIED/UNKNOWN ERROR MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AROUND 5:45AM. AS PART OF THE PATIENT'S DIABETES REGIMEN, THE PATIENT STATED SHE IS ON INSULIN. THE FOLLOWING DAY AFTER THE ALLEGE ISSUE BEGAN, THE PATIENT INDICATED SHE RESPONDED TO EATING LESS FOOD AND/OR DRINK. THE PATIENT REPORTEDLY FELT TINGLING ON THE FEET, BURNING ON THE LEG AND FEET, AND HAD SYMPTOMS OF BLURRY VISION 2 DAYS AFTER THE ALLEGED ISSUE BEGAN. ON (B)(6) 2011 AT 8:15PM, THE PATIENT INDICATED SHE WENT TO HER LOCAL (B)(6) PHARMACY FOR ADVICE AND TO INQUIRE HOW MUCH INSULIN TO TAKE. HOWEVER, IT IS NOT SPECIFIED WHAT ADVICE OR INFORMATION THE PATIENT RECEIVED FROM THE PHARMACY. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT DENIED TESTING ON ANY OTHER BLOOD GLUCOSE DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED THE PATIENT HAD USED THE SUBJECT METER BEFORE AND THE METER WAS NOT MISUSED. PER THE CCA DOCUMENTATION, THE PATIENT WAS UNABLE/UNWILLING TO WALK THROUGH RESOLVING THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST ON THE SUBJECT METER AND REPORTEDLY BECAME HYPERGLYCEMIC AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening