BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3844294 · Received June 2, 2014

    Report

    Report Number
    2954323-2014-00618
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 5, 2014
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE REPORTED MEDICAL EVENT WAS RELATED TO A TRAINING ISSUE. THEREFORE NO PRODUCT WILL BE RETURNED FOR INVESTIGATION. CUSTOMER WAS EDUCATED THAT THE LIGHT CAN ONLY BE ENGAGED FOR EITHER THE DISPLAY OR THE PORT, BUT NOT BOTH AT THE SAME TIME. CUSTOMER WAS PROVIDED WITH A NEW METER WITH A LARGER DISPLAY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER CALLED CUSTOMER SERVICE TO REQUEST TRAINING IN HOW TO USE THE BACKLIGHT ON HER ADC BLOOD GLUCOSE METER; SPECIFICALLY HOW TO MAKE THE LIGHT WORK FOR BOTH THE DISPLAY AND THE PORT AT THE SAME TIME. CUSTOMER FURTHER REPORTED THAT ON (B)(6) 2014, SHE ATTEMPTED TO TEST USING HER ADC BLOOD GLUCOSE METER BUT NOTED THE BACKLIGHT DIDN'T STAY ON LONG ENOUGH AND THE SCREEN WAS TOO SMALL AND BECAUSE OF THIS, SHE COULD NOT SEE THE RESULT ON THE DISPLAY. CUSTOMER NOTED EXPERIENCING "DIZZINESS, A HEADACHE AND THIRST". PARAMEDICS WERE CALLED AND TRANSPORTED HER TO A LOCAL HEALTHCARE FACILITY WHERE SHE WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH AN UNKNOWN AMOUNT OF INSULIN. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321956 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention