BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 3895398 · Received June 25, 2014

    Report

    Report Number
    2954323-2014-00716
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    November 19, 2015
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    PRODUCT PROBLEM" OF THE INITIAL MDR WAS LEFT UNCHECKED. THIS REPORT IS BEING UPDATED AS PART OF A RETROSPECTIVE REVIEW OF ISSUES RELATED TO THE REPORTABLE CONFIRMED MALFUNCTION LIST. THIS SECTION HAS BEEN UPDATED TO REFLECT THE CORRECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE WAS UNABLE TO TEST DUE TO HIS ADC BLOOD GLUCOSE METER NOT POWERING ON WITH BUTTON PRESS OR TEST STRIP INSERTION. CUSTOMER FURTHER REPORTED THAT ON (B)(6) 2014 AT APPROXIMATELY 4:00PM HE "FELT COLD, SWEATY, AND DIZZY". CUSTOMER'S WIFE CALLED THE NURSE AND CUSTOMER WAS ADVISED TO TAKE A TEASPOON OF SYRUP/SUGAR. CUSTOMER SELF-PRESENTED TO THE EMERGENCY ROOM AND UPON HIS ARRIVAL, HE WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH AN UNSPECIFIED MEDICATION "TO BRING HIS SUGAR UP" VIA INTRAVENOUS INFUSION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370466 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention